Location: Gangtok, Ranipol, Guwahati, Halol, Baska, Vadodara.

Execute the preparation of SOPs, General procedures, updating masters in applicable ERP system, archival of documentation as per current Good Manufacturing Practices requirements.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

1. To prepare and revise QA SOP as per GQS and GSOP.

2. Establish control system for tracking SOPs due for revision, alerting stake holders and ensuring timely revision due to periodic review, recommendation from regulatory or corporate, in line with Global Quality documents.

3. Issuance and Retrieval of controlled copy of SOP’s and Other GMP documents of site.

4. Handling (Issuance, Retrieval, Archival and Destruction) of GMP documents as per policy.

5. Review, updation and maintenance of relevant Quality Assurance documents in accordance with regulatory requirement.

6. Review of master BMR/BPR.

7. Issuance of BMR/BPR and maintaining master list of BMR/BPR.

8. To check and confirm manufacturing BOM of raw materials in ERP System. To deactivate the manufacturing BOM as per instruction of Plant Regulatory.

9. To provide either hard copy or scan copy of GMP documents to RA on request.

10. Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

Science and Pharmacy Graduates or Equivalent

Fresh Science and Pharmacy Graduates

REQUIRED SUCCESS ATTRIBUTE

· Knowledge of GxP’s, cGMP and other regulatory requirements.

· Attention to detail

· Initiative

· Learning Agility

· Compliance

Secondary Success Attributes

· Collaboration

· Effective Communication

· Passion

Roles

Additional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic site responsibilities to higher level

Downward Delegation – Operational responsibilities to direct reports or similar job role See Less