Associate III Design Quality Job at Baxter (Ahmedabad)

Associate III Design Quality

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies
To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Associate III, Design Quality

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies
To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for parents
Continuing education / Professional development
Employee health and wellness benefits
Paid time off
2 days per year for volunteering

Fulltime

Associate III, Design Quality

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Associate III, Design Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc.
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc.
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Associate III, Design Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical formulation techniques like lyophilization, homogenization, etc.
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc.
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Associate III, Design Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad, Gujarat

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc.
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc.
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Associate III, Design Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Good knowledge of product development and life cycle management
Good knowledge of critical formulation techniques like lyophilization, homogenization, etc.
Good knowledge of regulatory requirements for ANDA/NDA submissions
Good experience of responding regulatory queries
Good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

Participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
Participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
Review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
Be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
Review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc.
Carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
Impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
Ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Quality Engineer Associate III

The Quality Associate III (Quality Engineer) is a key individual contributor res...

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Science or Engineering required
5 or more years experience in IT, Engineering, Science or related field
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Strong technical writing skills
Must be able to clearly document audit findings within audit reports
Strong technical, analytical and problem solving skills
Good interpersonal, communication, influencing, negotiation skills
Understand scientific strategies and be able to invent new methods or new avenues of investigation
Good interpersonal/communication/influencing/negation skills
Good project management skills

Job Responsibility

Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor
Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation
Manage activities in achieving defined quality goals in an efficient, accurate and timely manner
Ensure business needs and timeliness requirements of the department are met or exceeded
Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
Maintain a high level of expertise in current regulatory requirements
Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Associate III Design Quality

Job Description

Job Responsibility

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What we offer

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