Deputy manager/Asst.Manager/Sr.Executive/ Executi - Quality Assurance.

QA( AQA) & (IPQA)

**Responsibilities:**

- Review the Audit Trail Report and SOPs related to Quality Control (Chemical & Microbiology).

- Review Stability Protocols and Reports.

- Investigate and resolve Out-of-Limits (OOL), Out-of-Trend (OOT), and Out-of-Specification (OOS) occurrences.

- Review equipment and usage logbooks for QC and microbiology.

- Review the calibration records for QC and microbiology equipment.

- Follow up on the closure of deviations, change controls, and CAPAs in the QC area.

- Log OOS, OOT, and OOL occurrences and update the relevant databases and logbooks.

- Review analytical method validation, study protocols, Records of Analysis (ROA), and reports.

- Verify Media Fill vials.

- Review Environmental Monitoring Plan (EMP), water trends, specifications, and testing results.

- Review Standard Test Procedures (STPs) and Good Trading Practice (GTP) materials/products.

- Prepare and review Quality Risk Assessment documents.

- Prepare and review the Annual Product Quality Review (APQR).

- Review the Record of Analysis for raw materials (RM), packaging materials (PM), in-process samples, validation samples, and finished products (FP).

- Review RM and PM sampling plans and approvals.

**Qualifications:**

- Only candidates with pharmaceutical experience and those available to join immediately or within 30 days should apply.

**Additional Responsibilities:**

- Lead and supervise In-Process Quality Assurance (IPQA) activities on the manufacturing and packaging shop floor.

- Ensure strict adherence to current Good Manufacturing Practices (GMP) and real-time documentation.

- Perform line clearance and stage-wise verification of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).

- Evaluate critical process parameters and support continuous process verification.

- Handle and review deviations, CAPAs, and change controls related to in-process operations.

- Conduct internal audits and assist during regulatory inspections (e.g., CDSCO, WHO).

- Monitor cleanroom behavior, gowning practices, and environmental conditions.

- Ensure timely review and closure of quality events.

- Train junior QA and production staff on SOPs and updated regulations.

- Review analytical raw data for compliance with cGMP, GLP, and regulatory standards.

- Supervise analytical documentation, including method validations, instrument qualifications, and stability reports.

- Perform and lead audit trail reviews for chromatographic software (HPLC/GC).

- Oversee the data integrity program and ensure adherence to ALCOA+ principles.

- Manage and coordinate the investigation of laboratory incidents such as OOS and OOT, providing QA oversight during investigations.

- Collaborate with QC and Regulatory Affairs (RA) teams to ensure audit readiness.

- Review and approve analytical method transfer and validation protocols.

- Lead internal quality audits and support external inspections.

- Provide guidance and mentoring to junior analysts and Assistant Quality Assurance (AQA) staff.

Perks and benefits

As per company standard