Job Description

Key Responsibilities : 1. Quality Control Operations

• Supervise and manage the QC team and laboratory activities.
• Review and approve raw material, packaging material, and finished product testing results.
• Ensure timely and accurate testing of samples (raw materials, in-process, stability, and finished products).
• Manage the preparation and review of COAs (Certificates of Analysis).

2. Regulatory Compliance

• Ensure compliance with regulatory requirements (e.g., WHO GMP, USFDA, MHRA, etc.).
• Stay updated on changes in pharmaceutical quality standards and regulatory guidelines.
• Prepare for and assist during internal and external audits and inspections.

3. Documentation and Reporting

• Review and maintain QC documents such as test reports, stability reports, and SOPs.
• Ensure proper calibration and validation records for all QC instruments.
• Submit monthly/quarterly QC reports to the management.

4. Team Management

• Train and mentor QC staff on laboratory techniques, safety procedures, and compliance requirements.
• Manage workloads and allocate resources effectively.
• Conduct performance evaluations and support staff development.

5. Laboratory Equipment and Processes

• Oversee the procurement, maintenance, and qualification of laboratory equipment.
• Implement and monitor adherence to laboratory safety protocols.
• Ensure proper storage and use of chemicals, reagents, and reference standards.

6. Investigation and Troubleshooting

• Conduct investigations for OOS (Out of Specification), deviations, and laboratory errors.
• Propose CAPAs (Corrective and Preventive Actions) and ensure their implementation.

7. Stability Studies

• Oversee stability studies to determine product shelf life.
• Monitor the stability chamber conditions and evaluate data trends.

8. Continuous Improvement

• Identify opportunities to improve QC processes, reduce errors, and enhance efficiency.
• Participate in cross-departmental discussions to optimize quality practices.

Qualifications :

• Education : Bachelor's/Master's degree in Pharmacy, Chemistry, Microbiology, or related field.
• Experience : 6-10 years in pharmaceutical QC, with at least 2-3 years in a supervisory role.
• Knowledge :
• Hands-on experience with HPLC, GC, UV, FTIR, and other analytical instruments.
• Deep understanding of regulatory guidelines like ICH, GMP, and GLP.

Skills Required :

• Strong analytical and problem-solving skills.
• Excellent leadership and team management abilities.
• Proficiency in data interpretation and technical writing.
• Knowledge of LIMS (Laboratory Information Management Systems).
• Effective communication and interpersonal skills.

Job Type: Full-time

Pay: ?12,511.82 - ?43,352.52 per month

Benefits:

• Health insurance
• Paid sick time
• Provident Fund

Schedule:

• Day shift

Experience:

• total work: 4 years (Required)
• pharma company: 4 years (Required)

Work Location: In person