Sr Executive I, Quality Control Job at Baxter (Ahmedabad)

Sr Executive I, Quality Control

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

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Job Responsibility

To ensure and carry out the analysis of stability sample and all other activities as per Standard Operating Procedure (SOP)
To get involve and support in investigation of failure of any material or product in case of any out of specification (OOS) or Out of trend (OOT) or laboratory incident or non-conformity and take corrective and preventive actions
To raise and implement change control or document change request wherever necessary
To follow and ensure Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) inside Stability lab
To ensure availability of the working & impurities standards as per various pharmacopoeia
To assist Supervisor in preparation of SOP and give suggestions to improve system performance
To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule
To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same
To work for lab readiness for audit and ensure compliance in Laboratory

What we offer

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

Sr Executive I, Quality Assurance

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

To take instructions from supervisor or QA Head to manage Document Control activity
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
To review and verify that any GDP issues have been addressed
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
To issue completed records from record room and ensure its storage, achieve & timely disposition
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment

What we offer

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

Sr Executive I, Quality Systems

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

To archive master copy and superseded copy of documents in documents record room
To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP
To ensure proper storage and archival of documents in the Central record room
To maintain documents inventory for record room and to intimate the document owner on the due date of document retention period which is going to get due
To ensure access of central record room and BaxCabinet access for document process to required person as per request
To ensure departmental NCR initiate on time and prepare investigation report for NCR
To ensure closure of DCR/CCM/NCR/CAPA task within time frame
To ensure that all document records for doc-cell are in line with cGMP and regulatory compliance
To issue controlled copies of documents to the copyholders
To maintain blank logbook inventory and issue logbook and daily notebook based on request

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

Sr Executive I, Quality Assurance

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

To take instructions from Supervisor and shift lead to perform the shift activity
To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records
To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR
To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place
To collect In-process samples, finished product samples, and other samples timely submission into QC/micro
To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine and any other equipment’s etc
To ensure the respective documents to be destructed as per approved procedure
To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured
To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification
To execute the approved Corrective and Preventive Action (CAPA) with in define timeline

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

Sr Executive I, Quality Assurance

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

To take instructions from supervisor or QA Head to manage Document Control activity
To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards
To review and verify that any GDP issues have been addressed
To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS)
To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room
To issue completed records from record room and ensure its storage, achieve & timely disposition
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products)
To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement
To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site
To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment

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

Sr Executive I, Quality Systems

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

To archive master copy and superseded copy of documents in documents record room
To maintain data of document inventory and ensure all documents well-arranged and maintained in central record room as per SOP
To ensure proper storage and archival of documents in the Central record room
To maintain documents inventory for record room and to intimate the document owner on the due date of document retention period which is going to get due
To ensure access of central record room and BaxCabinet access for document process to required person as per request
To ensure departmental NCR initiate on time and prepare investigation report for NCR
To ensure closure of DCR/CCM/NCR/CAPA task within time frame
To ensure that all document records for doc-cell are in line with cGMP and regulatory compliance
To issue controlled copies of documents to the copyholders
To maintain blank logbook inventory and issue logbook and daily notebook based on request

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

Sr. Quality Executive

The Sr. Quality Executive at Hindustan Unilever Limited is responsible for ensur...

Location

India , Dadra and Nagar Haveli and Daman and Diu

Salary:

Not provided

Unilever

Expiration Date

Until further notice

Requirements

Bachelor's degree in Food Technology, Chemical Engineering, Pharmacy, or a related scientific discipline. Master's degree preferred
5-8 years of experience in Quality Assurance/Quality Control within a fast-moving consumer goods (FMCG) manufacturing environment, preferably in food, home care, or personal care sectors
In-depth knowledge of Quality Management Systems (e.g., ISO 9001, FSSC 22000, GMP) and their practical application
Proven experience in conducting audits, root cause analysis, and implementing CAPA programs
Strong understanding of statistical process control (SPC) and other quality improvement methodologies
Familiarity with relevant regulatory requirements and industry standards
Excellent analytical, problem-solving, and decision-making skills
Strong communication, interpersonal, and leadership abilities, with the capacity to influence cross-functional teams
Proficiency in using quality management software and Microsoft Office Suite
Ability to work independently and as part of a team in a fast-paced, dynamic environment

Job Responsibility

Develop, implement, and maintain robust Quality Management Systems (QMS) in accordance with company policies and regulatory requirements
Conduct regular quality audits, inspections, and assessments of manufacturing processes, raw materials, in-process materials, and finished goods to identify non-conformances and recommend corrective actions
Lead and facilitate root cause analysis for quality deviations, consumer complaints, and process failures, implementing effective preventive and corrective actions (CAPA)
Collaborate with R&D, Production, Supply Chain, and other cross-functional teams to integrate quality considerations throughout the product lifecycle, from concept to commercialization
Monitor key quality performance indicators (KPIs), analyze data, and generate reports to track trends, identify areas for improvement, and present findings to management
Ensure compliance with all relevant national and international quality standards, including ISO, GMP, and other industry-specific regulations
Provide training and guidance to production staff on quality procedures, best practices, and safety protocols
Manage and resolve consumer complaints and product quality issues efficiently and effectively, ensuring consumer satisfaction and brand reputation
Participate in supplier qualification and management processes, assessing supplier quality systems and performance
Drive continuous improvement projects aimed at enhancing product quality, reducing waste, and improving operational efficiency

Fulltime

Sr. Manager Quality Control - Chemistry

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Holly Springs

Salary:

142103.85 - 192258.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
Implement effective digital tools for leading the organization
Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
Participate in regulatory agency inspections and support site licensure and inspection readiness activities

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

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Sr Executive I, Quality Control

Job Description

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