1. Role Purpose
To lead and manage the Quality Control function, ensuring timely testing, compliance with regulatory standards, and release of raw materials, intermediates, and finished products in line with GMP and organizational quality systems.
2. Key Responsibilities
A. Strategic & Leadership Responsibilities
- Lead the Quality Control department with full ownership of laboratory operations.
- Develop and implement QC strategies aligned with organizational goals.
- Drive continuous improvement in quality systems and laboratory efficiency.
- Act as a key stakeholder during regulatory and customer audits.
B. Operational Management
Oversee testing and release of:
- Raw Materials (RM)
- Intermediates
- Finished Goods (FG)
- Ensure daily planning and allocation of work to analysts based on priorities.
- Monitor laboratory productivity and turnaround times.
- Ensure proper functioning of all QC instruments and systems.
C. Quality Systems & Compliance (QMS)
Ensure effective implementation of:
- OOS (Out of Specification)
- OOT (Out of Trend)
- Deviations
- Laboratory incidents
- Review and approve investigation reports and ensure timely closure.
- Maintain data integrity and compliance with ALCOA+ principles.
- Review and approve SOPs, STPs, and specifications.
D. Analytical & Technical Oversight
Review analytical data from:
- HPLC, GC
- UV, IR, KF
- Particle Size Analyzer
Approve:
- Method Validation
- Method Verification
- Method Transfer protocols and reports
- Ensure calibration and qualification of instruments.
- Provide technical guidance to the team on complex analytical issues.
E. Audit & Regulatory Compliance
Lead and handle:
- Regulatory audits (USFDA, EU GMP, WHO, ANVISA, etc.)
- Customer audits
- Ensure audit readiness at all times.
- Address audit observations and ensure CAPA implementation.
F. Training & Team Development
- Train and develop QC team members.
- Ensure qualification and certification of analysts.
- Build a high-performance team culture.
- Conduct regular performance reviews and skill assessments.
G. Cross-Functional Coordination
Coordinate with:
- Production
- QA
- PPIC (Production Planning)
- Participate in planning meetings for dispatch and production timelines.
- Support investigations and product quality issues.
H. Documentation & Reporting
- Ensure proper documentation and record maintenance.
- Review and approve:
- Analytical reports
- Protocols and validation documents
- Provide periodic reports to management on QC performance.
3. Qualifications & Experience
- Education: M.Sc. in Chemistry (Organic/Analytical preferred)
- Experience: 1520+ years in Quality Control (Pharma/API industry)
- Minimum 5+ years in leadership role
You may reach out to me: 8637085495 / 9679617228
