Validation - G12C - Halol - I

SUN PHARMA; Panchmahal District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma in Halol-I is seeking a Senior Executive to lead qualification and requalification activities for sterile formulations, ensuring protocol reviews and cGMP compliance. You will sign off on critical documents and manage calibration and SOP updates.

Ideal candidates hold a Bachelor or Master of Pharmacy with 7+ years of relevant experience in a pharmaceutical GMP setting, with strength in equipment qualification and regulatory documentation.

Qualifications

• Bachelor or Master of Pharmacy is required.
• Minimum 7+ years of experience in a GMP/pharmaceutical environment.
• Experience with qualification protocols, reports and cGMP documents.

Responsibilities

• Execute, compile and ensure qualification/requalification for equipment, utilities and facilities used for sterile formulations.
• Review Qualification Protocols and Qualification Reports.

Education

Bachelor / Master of Pharmacy

Job description

Job Description:

Title:

Senior Executive

Business Unit:

SGO

Job Grade

Location :

Halol-I

Key Responsibilities

• Execution, compilation and compliance of qualification and requalification activities of Equipment’s, Utilities and Facility for sterile formulations.
• Review of Qualification Protocol and Qualification Report.

Tasks:

1. HE is authorize to sign (as a doer or reviewer):
2. Qualification protocol/ Report.
3. Balance, Weight box and weight calibration report/ certificates and schedule.
4. Instrument calibration and equipment requalification schedule.
5. Equipment & Instrument Addition / Deletion.
6. Calibration related activity.
7. Regulatory Summary & Query response.
8. Document issuance and Retrieval.
9. Non-viable particle count test schedule and test certificates
10. Filter integrity test schedule and Filter integrity test certificates
11. Preparation and revision of QE/Validation SOPs.
12. Preparation and Updation of cGMP documents. E.g. EQMP (Equipment Qualification Master Plan).
13. Temperature mapping activity.
14. Handling of any other activities / tasks allotted by department head.

Travel Estimate

Low

Job Requirements

Educational Qualification

Bachelor / Master of Pharmacy

Experience

7+ years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).