QA / QC Manager

Position: QC & QA Manager

Experience: 5+ years

Department: Quality Control (QC) and Quality Assurance

Location: NANA CHILODA

Job Purpose

To lead the Quality Control and Quality Assurance function by managing a team of 15–20 members and ensuring smooth execution of QC & QA testing activities including HPLC, GC, Dissolution, assay, and related analytical tests. Responsible for planning, review of analysis results, troubleshooting, method development, method validation, stability studies and ensuring compliance with NABL and applicable regulatory requirements (FDCA and related GMP/quality standards).

Key Responsibilities

1. Lead and manage QC & QA operations and ensure timely testing.
2. Plan and coordinate analytical testing activities across HPLC, GC, and Dissolution.
3. Review test results (Assay, Impurities, dissolution profiles, etc.) and ensure data integrity and compliance.
4. Troubleshoot analytical issues in HPLC/GC/dissolution systems including chromatography problems, integration issues, system suitability failures, dissolution equipment issues, and method-related deviations.
5. Handle method development and support/lead method validation activities as per internal SOPs and validation protocols.
6. Ensure accurate calculations for Assay and Dissolution testing (e.g., % assay calculations, sample/standard calculations, content uniformity-related computations if applicable, dissolution acceptance criteria, mean/individual values, and profile evaluation).
7. Manage documentation and analytical records, including batch test records, CoAs inputs, instruments logs, calibration/qualification support, and instrument maintenance coordination.
8. Prepare for and support internal audits; ensure readiness for NABL audits.
9. Maintain compliance with FDCA-related expectations and internal quality systems (as applicable).
10. Coach, train, and develop the QC and QA team; ensure adherence to GMP, safety, and laboratory practices.
11. Participate in CAPA/Deviation/OOS/OOT investigations related to QC analytical testing.

Required Technical Skills

Strong working knowledge of:

• HPLC (method setup, system suitability, chromatographic troubleshooting)
• GC (method understanding, troubleshooting, peak/integration issues)
• Dissolution testing including IR/USP-based dissolution approaches (as applicable)
• Strong capability in:
• Assay and dissolution calculations
• Understanding acceptance criteria and handling analytical variability

Demonstrated experience in:

• Analytical troubleshooting
• Method development and method validation

Qualification

B.Pharm

M.Pharm

B.Sc

M.Sc

(Preferred: candidates with strong analytical background in pharmaceutical testing.)

Experience Requirements

• Minimum 5+ years experience in pharmaceutical QC/analytical testing.
• Proven leadership ability managing 15–20 QC personnel.
• Desired Attributes
• Strong attention to detail and data integrity mindset.
• Ability to work under pressure and handle multiple batch schedules.
• Good communication skills for coordination with Production, QA, and regulatory documentation teams.
• Ability to drive continuous improvement in analytical processes and lab workflow.
• What You’ll Be Responsible For (Summary)
• QC testing planning, result review, troubleshooting, method dev/validation
• Team management (15–20)
• Audit readiness for NABL and compliance understanding for FDCA-related requirements