Job Description

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