Title:  Senior Officer-Quality Control

Title:

Senior Officer-Quality Control

Business Unit:

Global Quality and Compliance

Job Grade

G12B /Senior Officer

Location:

Mohali

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Position Summary –

• Ensure compliance of cGMP and safety standards in laboratory.
• Ensure timely completion of periodic calibration, performance verification, preventive maintenance and qualification of instruments.
• Ensure timely closure of instrument breakdowns.
• Initiation and approval of change control, lab event, deviation, OOS, OOT & CAPA etc.in trackwise.
• Provide monthly metrics data as per management requirements.
• To review/approval of calibration calendar and calibration master list of instrument/devices and compliance of monthly and yearly calendar.
• AMC of instrument and external calibrations.
• Support in timely backup of all computer related software used in laboratory.
• Responsible for laboratory investigation and root cause analysis of OOS, OOT, Deviation and its characterization and accordingly implementation of appropriate CAPA.
• Manage resource planning of (log books, chemicals, glassware, chromatographic columns and laboratory standards).
• Ensure the availability, usage, storage and qualification (if applicable) of laboratory standards, chemicals and chromatographic columns.
• Support in up gradation and installations of software being used in laboratory as per cGMP requirement.
• Participate in all internal, external and regulatory inspection at site.
• To follow and ensure compliance to EHS standard in laboratory.
• Review and Approval of qualification and calibration records.
• Raise Capex proposals and ensure the capitalization of the budgeted items as per requirements.
• Assure all time readiness of site for regulatory agency inspections/ internal audits and appropriate implementation of corrective actions regarding observation made by the agencies/ internal audit teams.
• GRN approval in SAP and other transactions as per requirement.
• Approval of purchase request coordination with purchase team and associated vendors to support QC operations.
• Responsible for effective managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals.

Travel Estimate

Low

Job Requirements

Educational Qualification

Pharmacy (M. Pharma/B. Pharma)

Microbiology (M.Sc./B. Sc)

Experience

4-7 years of relevant experience in Pharmaceutical Industry

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).