Quality Control (QC) Manager

1. Sample and Testing Management:

Oversee sampling, testing, and management of raw materials, in-process, finished products, packing materials, and stability samples.

Ensure compliance with GLP, GMP, and GDP guidelines for laboratory operations.

2. Compliance and Validation:

Approve and review protocols for analytical method validation, method transfer, process validation, cleaning validation, and other quality studies.

Monitor calibration schedules, instrument qualifications, and validation activities.

3. Quality Systems Management:

Manage QMS activities, including OOS/OOT investigations, CAPA, deviations, change control, and lab events.

Ensure adherence to data integrity and document retention policies.

4. Audits and Reviews:

Conduct internal audits and support external audits, including vendor and regulatory audits.

Participate in management reviews and drive continual improvement initiatives.

5. Team Management and Training:

Train and develop team members, ensuring alignment with SOPs and quality standards.

Recruit and onboard new team members for the QC department.

6. Process and Instrumentation Oversight:

Coordinate maintenance, qualification, and troubleshooting of instruments.

Monitor process validation, cleaning verification, and laboratory safety.

7. Documentation and Reporting:

Review and approve QC-related documentation such as test methods, specifications, and validation reports.

Support regulatory document submissions and ensure compliance with pharmacopeial updates.

8. Other Responsibilities:

Implement lifecycle management for projects and manage monthly data reports.

Support quality improvements, risk assessments, and corrective actions in coordination with QA.

Qualifications and Skills:

In-depth knowledge of GLP, GMP, and quality control processes.

Strong leadership, problem-solving, and communication skills.

Proficiency in laboratory instruments, QMS tools, and regulatory guidelines.