Associate, In-Process Quality Assurance Mfg/PkgTitle: Associate, In-Process Quality Assurance Mfg/PkgDepartment: Quality Assurance Operation Support
Reports To: Quality Assurance Manager/VP Of QARole Overview
The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs in-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas Of ResponsibilityIPQA – Level 1: To support in-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements.
Key Responsibilities
Manufacturing Support:
Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes.
Perform in-process checks: Blend uniformity sampling, tablet/capsule weight variation, hardness, friability, and disintegration tests etc as applicable.
Verify equipment cleaning and area hygiene as per SOP.Collect and label in-process and stability samples under supervision.
Packaging Support:- Ensure line clearance before packaging activities.
- Perform in-process checks: Batch number and expiry date printing, label application and carton sealing, primary and secondary packaging integrity etc as applicable.
- Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels).Documentation
- Record observations in IPQA checklists, logbooks, and batch records.
- Maintain GMP documentation in real-time (legible and error-free).Escalate any deviation or abnormality immediately to the QA Executive/Supervisor.
- Compliance & SafetyAdhere to company GMP, SOP, and hygiene policies.
Use PPE:
during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other Responsibilities Including Safety:
IPQA:
Level 2: To independently perform and document in-process quality assurance activities at all critical stages of manufacturing and packaging of nutraceutical products, ensuring compliance with GMP, SOPs, and regulatory requirements.
Key Responsibilities:
Manufacturing Stage (Granulation, Blending, Compression, Encapsulation, Coating) Carry out and document line clearance activities before starting each manufacturing in-process checks independently: Blend uniformity sampling, tablet/capsule weight variation, hardness, friability, thickness, and controls as per BMR equipment cleanliness status, calibration, and logbook entries. Monitor and record environmental conditions in production areas (temperature, RH, differential pressure).Packaging Stage Conduct line clearance for primary and secondary packaging (bottles, strips, blister, cartons).Perform and document: Batch coding verification (batch no., Mfg/Exp date), packaging material correctness (labels, leaflets, cartons), sealing integrity checks (blisters, induction seals).Online rejection bin and reconciliation checks. Ensure correct usage of approved packaging materials with status labels.
Documentation & Compliance:
Fill Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in real-time.
Record IPQA observations and results as per SOPs (legible and error free).Initiate and report deviations, OOS/OOT, and non-conformities to QA Supervisor/Manager.
Support CAPA implementation and change controls.
General QA DutiesEnsure compliance with GMP, GLP, and data integrity principles.
Follow gowning protocols, hygiene, and safety measures in production areas.
Assist during internal audits and regulatory inspections by providing accurate documentation and
up work following the completion of a shift.
Meets all safety expectations and follows all safety practices.
Works extended hours and occasional weekend overtime.
Other Responsibilities Including Safety:
IPQA:
Level 3: To lead and monitor in-process QA activities during nutraceutical manufacturing and packaging operations. Ensure compliance with GMP, regulatory standards, and internal SOPs by supervising IPQA teams, reviewing records, and addressing quality
Responsibilities:- IPQA Oversight – Manufacturing & Packaging
- Supervise and verify line clearance activities across all manufacturing and packaging areas.
- Ensure compliance with critical process parameters (CPPs) and critical quality attributes (CQAs).Review and approval: In-process checks: weight variation, hardness, friability, disintegration etc as applicable.
- Environmental monitoring records
- Equipment and area cleaning records
- Coordinate and monitor sampling activities for in-process, finished products and stability studies.
- Review And Verification
- Review and verify completed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).Cross-check reconciliation of raw materials and printed packaging
proper use of status labels (approved/rejected/quarantine).Deviation & CAPA Management
Investigate and document process deviations, non-conformances, and OOS/OOT incidents.
Lead root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA).Coordinate with cross-functional teams (Production, QC, Regulatory Affairs) to ensure closure of quality events.
Audit & Compliance:
Ensure readiness for internal, external, and regulatory audits (FSSAI, WHO-GMP, USFDA, etc.).Conduct routine GMP audits, spot checks, and area inspections. Train shop-floor personnel on data integrity, documentation practices, hygiene, and gowning protocols.
Team Coordination:- Guide and mentor IPQA Level 1 and Level 2 personnel.
- Allocate daily QA responsibilities and monitor adherence to QA procedures.
- Conduct on-the-job training for new team members.
- Other Responsibilities Including Safety:
- Cleans up work following the completion of a shift.
- Meets all safety expectations and follows all safety practices.
- Works extended hours and occasional weekend overtime.
- Other Responsibilities Including Safety:
- Works in a safe and responsible manner to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements. Keeps management informed of area activities and of any significant problems.
Requirements: Education & Qualification:
IPQA:
Level 1: 0–1 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
IPQA:
Level 2: Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
