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 - ₹60,000.00 per month
Education:
Experience:
Work Location: In person
