QA Manager

Habitare Pharmaceuticals Private Limited is a premier third-party pharmaceutical product manufacturing company, specializing in Non-Beta Tablets, Capsules, Oral Liquids, External Applications, Ointments, Gels, Medicated Creams, Lotions, and more.

Roles and Responsibility:

• Ensure compliance with cGMP, GLP, GDP, WHO, ICH, and regulatory guidelines.
• Establish, implement, and monitor Quality Management Systems (QMS).
• Oversee batch release, documentation control, and product quality reviews.

2. Documentation & SOP Management

• Create, review, and approve SOPs, validation protocols, batch manufacturing records, and related documents.
• Ensure proper document control, revision management, and archival practices.

3. Compliance & Regulatory Support

• Prepare for and actively participate in regulatory audits (FDA, WHO, GMP, ISO, State FDA etc.).
• Coordinate internal and external audits & ensure timely closure of observations (CAPA management).
• Review regulatory submissions related to QA.

4. QMS (Quality Management System) Management

• Responsible for change control, deviation management, OOS/OOT investigations, and preventive actions.
• Ensure timely investigation and root cause analysis.
• Maintain risk assessment and mitigation processes.

5. Batch Release & Review

• Review batch manufacturing and packing records for accuracy and completeness.
• Approve batches for release, ensuring compliance with specifications.
• Oversee raw material, in-process, and finished product quality assurance activities.

6. Training & Team Management

• Train plant personnel on GMP, SOPs, quality standards, and best practices.
• Lead and mentor QA team members.
• Promote a strong culture of quality across departments.

7. Validation & Qualification

• Oversee equipment qualification (DQ/IQ/OQ/PQ) and validation of utilities, processes, cleaning, and analytical methods.
• Approve validation protocols and reports.

8. Vendor & Material Quality Assurance

• Approve and audit suppliers of raw materials, packaging materials, and service providers.
• Review vendor qualification and re-evaluation reports.
• Ensure material quality compliance.

9. Investigation & CAPA Management

• Lead investigations for deviations, non-conformities, and customer complaints.
• Implement effective CAPAs and track closure.
• Conduct periodic quality reviews and trend analysis.

10. Quality Risk Management

• Implement risk assessment tools (FMEA, HACCP, Fishbone, etc.).
• Ensure continuous improvement in plant quality operations.

11. Product Quality & Compliance Monitoring

• Oversee stability study programs.
• Monitor environmental conditions for manufacturing (temperature, RH, clean room classification).
• Ensure adherence to quality metrics and KPIs.

12. Coordination With Other Departments

• Work closely with Production, QC, Engineering, R&D, Warehouse, and management teams.
• Ensure smooth communication and resolution of quality-related issues.

13. Customer Complaint Handling

• Investigate market complaints.
• Implement corrective actions and preventive systems to avoid recurrence.

14. Continual Improvement

• Drive root cause analysis, quality improvement projects, and process optimization.
• Evaluate and implement industry best practices.

Job Type: Full-time

Pay: ₹12,000.00 - ₹40,000.00 per month

Education:

• Bachelor's (Preferred)

Experience:

• Tally: 1 year (Required)

Work Location: In person