Design Quality Job at Baxter (Ahmedabad)

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

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

New

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

Fulltime

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

Senior Design Quality Specialist

This position is for the Design Quality Specialist supporting the Baxter Clinica...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

3-5 years related engineering/science/quality experience
Familiarity with Minitab required
Experience in working with cross-functional teams, including technical and non-technical work
Ability to organize and present technical information with minimal assistance
Demonstrates solid organizational skills and ability to work independently

Job Responsibility

As Quality Reviewer performs document reviews to support design and labeling change controls
Collaborate with teams to provide mentorship for meeting Baxter QMS Requirements and External Quality Standards as appropriate
Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions
Facilitates small project teams as needed to accomplish team objectives
Supports Quality internal and external audits as the need arises
Applies DMAIC tools to investigate non-conformances and participates in (CAPA) related activities, including CAPA ownership

What we offer

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
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

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

Senior Design Quality Specialist

This position is for the Design Quality Specialist supporting the Baxter Clinica...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Science, or a related technical discipline
3-5 years related engineering/science/quality experience
Prior experience in product development, design and/or testing within medical device industry
Ability to travel up to approximately 10% as needed
Solid understanding of FDA Regulations, Design Controls and Change Control requirements
Display a technical understanding of engineering and product development principles and procedures
Possess basic understanding of DMAIC investigation tools
Familiarity with Minitab required
Experience in working with cross-functional teams, including technical and non-technical work
Ability to organize and present technical information with minimal assistance

Job Responsibility

As Quality Reviewer performs document reviews to support design and labeling change controls
Collaborate with teams to provide mentorship for meeting Baxter QMS Requirements and External Quality Standards as appropriate
Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions
Facilitates small project teams as needed to accomplish team objectives
Supports Quality internal and external audits as the need arises
Applies DMAIC tools to investigate non-conformances and participates in (CAPA) related activities, including CAPA ownership

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 starting 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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Design Quality Specialist

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

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Science, or a related technical discipline
3-5 years related engineering/science/quality experience
Solid understanding of FDA Regulations, Design Controls and Change Control requirements
Display a technical understanding of engineering and product development principles and procedures
Possess basic understanding of DMAIC investigation tools
Familiarity with Minitab required
Experience in working with cross-functional teams, including technical and non-technical work
Ability to organize and present technical information with minimal assistance
Demonstrates solid organizational skills and ability to work independently

Job Responsibility

As Quality Reviewer performs document reviews to support design and labeling change controls
Collaborate with teams to provide mentorship for meeting Baxter QMS Requirements and External Quality Standards as appropriate
Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions
Facilitates small project teams as needed to accomplish team objectives
Supports Quality internal and external audits as the need arises
Applies DMAIC tools to investigate non-conformances and participates in (CAPA) related activities, including CAPA ownership

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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Senior Design Quality Specialist

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