Job Description

Designation -

Quality Assurance (QA) In-Charge

Industry - Pharmaceutical
Experience:6-7 Years (QA Department - OSD Manufacturing: Tablets & Capsules)

Jejuri / Pune, Maharashtra

Qualification:

B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology)

Key Responsibilities

1. Documentation and Record Control

Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). Control, issue, and retrieval of SOPs, formats, logbooks, and quality documents. Maintain and update the Master Manufacturing Formula (MMF) and Standard Operating Procedures (SOPs). Ensure data integrity and compliance with GDP (Good Documentation Practices).

2. In-Process Quality Assurance (IPQA)

Provide

line clearance

for all manufacturing and packing operations (dispensing, granulation, compression, coating, and packing). Perform and monitor in-process checks (weight variation, hardness, thickness, disintegration, friability). Ensure online documentation and traceability of all manufacturing activities. Ensure environmental conditions and hygiene are maintained during production.

3. Deviations, Change Control & CAPA

Investigate and document

deviations

,

OOS

,

OOT

, and

market complaints

. Execute and monitor

Corrective and Preventive Actions (CAPA)

. Review and manage

Change Control

requests in coordination with Production & QC.

4. Validation & Qualification

Participate in

process validation

,

cleaning validation

, and

equipment qualification (IQ, OQ, PQ)

. Review validation protocols and reports to ensure scientific and regulatory accuracy.

5. GMP Compliance & Audits

Conduct routine

GMP inspections

and ensure compliance in all departments. Prepare and face

regulatory, WHO, and customer audits

. Ensure timely closure of audit observations with effective CAPA implementation.

6. Training & Quality Culture

Conduct internal

GMP, GDP, and hygiene training

sessions. Support quality improvement initiatives and maintain good documentation culture.

7. Batch Release

Review of QC analytical results and production records for final

batch release

. Ensure that only approved materials and validated equipment are used.

Skills & Competencies

In-depth knowledge of

cGMP, WHO, GLP, GDP

practices. Experience with

OSD (Tablet & Capsule)

manufacturing processes. Strong analytical, documentation, and communication skills. Ability to lead and mentor QA executives/officers. Audit handling and cross-functional coordination abilities.
Job Type: Full-time

Pay: ?40,000.00 - ?70,000.00 per month

Benefits:

Health insurance Provident Fund
Ability to commute/relocate:

Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:

Master's (Preferred)
Experience:

Pharmaceutical: 3 years (Required) total work: 7 years (Preferred) QA: 5 years (Required)
Work Location: In person