Executive

Sun Pharmaceutical Industries Ltd; Panchmahal District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Halol-I is seeking a Senior Executive to lead qualification and requalification activities for equipment, utilities and sterile facilities. The role requires hands-on execution, review of protocols and ensuring cGMP compliance.

You will manage calibration schedules, document generation, and QA responses while updating QE/Validation SOPs and related cGMP documents. A background in Pharmacy with 7+ years of experience is essential, with opportunity to

Qualifications

• Bachelor or Master of Pharmacy required.
• 7+ years of pharmaceutical experience.
• Experience with qualification and requalification of equipment, utilities and sterile facilities.

Responsibilities

• Execute, compile and ensure compliance of qualification and requalification activities for equipment, utilities and sterile facilities.
• Review Qualification Protocols and Qualification Reports.
• Manage calibration schedules and instrument validation.
• Prepare and update QE/Validation SOPs and cGMP documents.
• Handle regulatory summaries and QA queries.

Skills

Attention to detail

Regulatory knowledge

Documentation

Education

Bachelor/Master of Pharmacy

Tools

QE/Validation SOPs

Job description

Title:

Senior Executive

Business Unit:

SGO

Job Grade

G11B

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

• HE is authorize to sign (as a doer or reviewer):
• Qualification protocol/ Report.
• Balance, Weight box and weight calibration report/ certificates and schedule.
• Instrument calibration and equipment requalification schedule.
• Equipment & Instrument Addition / Deletion.
• Calibration related activity.
• Regulatory Summary & Query response.
• Document issuance and Retrieval.
• Non-viable particle count test schedule and test certificates
• Filter integrity test schedule and Filter integrity test certificates
• Preparation and revision of QE/Validation SOPs.
• Preparation and Updation of cGMP documents. E.g. EQMP (Equipment Qualification Master Plan).
• Temperature mapping activity.
• 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).