QMS Specialist - Pharmaceuticals Manufacturing

Job Summary

Key Responsibilities

1. Quality Risk Management:

Identify, assess, and mitigate quality risks associated with products and processes.

Implement and maintain a quality risk management system in accordance with regulatory guidelines.

2. Batch Manufacturing Record (BMR) Preparation:

Prepare and review BMRs for accuracy and compliance with regulatory requirements.

Ensure BMRs are properly approved, controlled, and distributed.

3. Process Validation:

Coordinate and execute process validation activities, including protocol preparation, execution, and reporting.

Ensure compliance with regulatory requirements and company standards.

4. Packaging Material Specification Preparation:

Develop and maintain packaging material specifications in accordance with regulatory requirements.

Ensure specifications are properly approved, controlled, and distributed.

5. Annual Product Quality Review (APQR):

Prepare and review APQRs for products, including trend analysis and recommendations for improvements.

Ensure APQRs are properly approved and distributed.

6. Cleaning Validation:

Coordinate and execute cleaning validation activities, including protocol preparation, execution, and reporting.

Ensure compliance with regulatory requirements and company standards.

7. Deviation Management:

Investigate and document deviations from established processes and procedures.

Ensure deviations are properly approved, controlled, and closed out.

8. Change Control Management:

Coordinate and execute change control activities, including assessment, approval, and implementation.

Ensure compliance with regulatory requirements and company standards.

9. Batch Card Preparation:

Prepare and review batch cards for accuracy and compliance with regulatory requirements.

Ensure batch cards are properly approved, controlled, and distributed.

10. Technology Transfer:

Coordinate technology transfer activities, including documentation, training, and execution.

Ensure compliance with regulatory requirements and company standards.

11. Coordination with RA & R&D:

Collaborate with Regulatory Affairs (RA) and Research & Development (R&D) teams on quality-related matters.

Ensure effective communication and coordination on quality-related activities.

Skill Requirements:

Master's degree in Pharmacy.

Minimum 3-7 years of experience in a QA/QMS role in the pharmaceutical industry.

Strong knowledge of regulatory requirements, including cGMP, ICH, and ISO 9001.

Excellent analytical, problem-solving, and communication skills.

Ability to work independently and lead cross-functional teams.

Salary & Benefits:

Competitive salary based on present package & industry norms.

Opportunities for professional growth and development.

Collaborative and dynamic work environment.

If you are an Eligible, motivated and detail-oriented professional with a passion for quality management, please submit your application.