The Assistant QA Manager is responsible for overseeing and enforcing compliance, document control, and shop-floor quality operations in accordance with cGMP, WHO-GMP, and statutory regulations. Key responsibilities include drug regulatory authorities, ensuring accurate and timely issuance and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR), acting as the central custodian for all Standard Operating Procedures (SOPs), and actively embedding a robust quality-first culture across all manufacturing operations

Key Responsibilities1. Government & Regulatory Liaison

- Serve as the primary point of contact for local and national drug control authorities (e.g., State FDA, CDSCO).
- Coordinate, prepare, and submit documentation required for manufacturing license endorsements, renewals, COPP (Certificate of Pharmaceutical Product), neutral code approvals, and site master files (SMF).
- Assist during official regulatory inspections and audits; lead the preparation of pre-audit checklists, audit rooms, and post-audit compliance reports (CAPA).
- Track and interpret revisions in drug rules, pharmacopeias (IP/BP/USP), and statutory guidelines, ensuring timely implementation at the site.

2. Master Documentation, BMR/BPR Custody & Timely Review

- Oversee the end-to-end lifecycle of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR), from generation and technical review to timely issuance to production.
- Perform rigorous line-by-line post-production reviews of completed BMRs/BPRs, analytical reports, and yield reconciliation to support batch release without operational delays.
- Investigate process deviations, out-of-specification (OOS) results, and yield discrepancies documented within batch records.

3. SOP Custodianship & Document Management





- Act as the official custodian of all site-wide Standard Operating Procedures (SOPs), Site Master Files, Specifications, and Standard Testing Procedures (STPs).
- Supervise the document control cell to enforce strict change control protocols for SOP authoring, revision, distribution, retrieval, and destruction.
- Ensure all departments adhere to periodic SOP review cycles, maintaining an audit-ready, central SOP inventory and archival system.
- Maintain physical and electronic logs to prevent the use of obsolete or unapproved documentation on the shop floor.

4. Shop-Floor Quality Assurance (IPQA) & QA Culture

- Drive shop-floor compliance by conducting routine walk-throughs, in-process checks, line clearances, and environmental monitoring oversight.
- Foster a "Quality at the Source" mindset across production, packaging, and warehouse teams through continuous coaching and daily quality briefings.
- Champion operational discipline: train shop-floor personnel on data integrity, Positive Documentation Practices (GDP), personal hygiene, and contamination control.
- Implement structured floor-level error-reduction initiatives and collaborate with manufacturing supervisors to address minor deviations proactively before they escalate.

5. Quality Management Systems (QMS) & Continuous Improvement

- Manage core QMS elements, including Deviations, Change Controls, Incidents, Corrective and Preventive Actions (CAPA), and Market Complaints.
- Lead root-cause analysis (RCA) investigations using structured tools (Fishbone, 5-Whys) to prevent recurrence of quality failures.
- Coordinate the site’s internal audit program (self-inspection) and monitor the time-bound closure of identified observations.
- Monitor Quality KPIs (e.g., Right-First-Time rates, deviation turnaround times, SOP review adherence) and report metrics to senior leadership.

Pay: ₹400,000.00 - ₹500,000.00 per year

Work Location: In person

📌 Assistant Manager QA (Rai)
🏢 Tabilac Pharmaceutical
📍 Rai