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 solid 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

📌 Manufacturing Chemist (Barwala)
🏢 Habitare Pharma
📍 Barwala