Executive

Sun Pharmaceutical Industries, Inc.; Northern (KY); Hybrid; USD 9,300 - 12,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. seeks a Senior Executive to lead qualification activities for sterile formulations, ensuring compliance and documentation accuracy. The role requires extensive review of protocols and reports, with responsibility for calibration and cGMP record maintenance.

The candidate should have Bachelor/Master of Pharmacy and 7+ years of relevant experience, contributing to regulatory submissions and quality systems at Sun Pharma.

Qualifications

• Qualification and requalification of equipment, utilities and facility for sterile formulations.
• Review of Qualification Protocol and Qualification Report.
• 7+ years of relevant experience in pharma/quality assurance or qualification.

Responsibilities

• Execute, compile and ensure compliance of qualification activities for equipment, utilities and facilities used in sterile formulations.
• Review of Qualification Protocol and Qualification Report.
• Maintain calibration schedules and related certificates.
• Update cGMP documents and SOPs; respond to regulatory queries.

Skills

Equipment qualification

Calibration

cGMP

Documentation

Quality assurance

Education

Bachelor/Master of Pharmacy

Tools

Qualification Protocol

Job description

Title:

Senior Executive

Business Unit:

SGO

Job Grade

G11B

Location :

Halol-I

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.

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).