Technician -(Grade 2) Engineering

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

Job summary

Sun Pharma in Halol-II, Gujarat seeks an Officer to oversee qualification and requalification activities for sterile formulations, including equipment, utilities and facility.

The role requires 4 years of experience and a Bachelor or Master of Pharmacy. Responsibilities include signing qualification protocol/reports, calibration schedules, and maintaining cGMP documents.

Join a team focused on compliance and quality in a fast-paced pharmaceutical environment with opportunities to grow.

Qualifications

• Qualification & requalification activities for sterile equipment, utilities and facilities.
• Review of Qualification Protocols and Qualification Reports.

Responsibilities

• Authorize to sign qualification protocol and qualification report as reviewer or doer.
• Prepare calibration and requalification schedules for instruments and equipment.
• Prepare and update QE/Validation SOPs and cgmp documents.
• Handle regulatory summaries and query responses.
• Document issuance and retrieval; arrange test certificates.

Skills

Qualification execution

Documentation & compliance

Regulatory knowledge

Education

Bachelor / Master of Pharmacy

Tools

QE/Validation SOPs

Job description

• 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.

Title

Officer

Business Unit

SGO

Job Grade

G12B

Location

Halol-II

Key Responsibilities

• 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

4 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).