Manager - Quality Engineering

Job Title

Projects & Engineering - QE

Business Unit

Sun Global Operations

Job Grade

G10 - Manager 1

Location :

New green field site (Pithampur – Indore)

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.”

Key Responsibilities

• Expertise in qualification of below process and equipment’s :
• To aware about the process like vial washing, depyrogenation, filtration, filling, manufacturing, lyophilizer, component washing and sterilization, terminal sterilization, isolators, CIP SIP skid, leak test, X ray inspection, VHP, clean utility like steam, compressed air, PW and WFI generation system, AHU, FFM,
• To handle the designing and qualification activity of process equipment’s like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox, manufacturing skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment’s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester, Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, external washing machine, leak test and X ray inspection machine, packing equipment’s etc.
• To handle the designing and qualification activity of Utility like Pure steam generation and distribution system, Purified water and WFI generation and distribution system, Nitrogen and compressed air generation and distribution system, AHU, FFM, LAF, area, cold storage etc.
• To handle indenting to procurement of accessories and equipment’s required for qualification activity of above equipment’s and area.
• To handle preparation, review and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification, performance qualification and Computer system validation and qualification.
• To prepare schedule for qualification activity, calibration activity, updation of status label of qualification activity etc.
• To prepare and execution of schedule requalification protocol of equipment’s and utility.
• To prepare new standard operating procedure for qualification activity and also review SOP of process equipment’s.
• To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
• To handle communication with vendor and procurement team on design parts of new equipment’s.
• To ensure compliance to cGMP and documentation for various qualification activities.
• Issuance, retrieval and storage of qualification documents.
• Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.
• Exposure of regulatory auditors like USFDA, EU, ANVISA, CANADA etc.
  
  

Travel Estimate

As required

Job Requirements

Educational Qualification

B. Pharmacy, M. Pharmacy

Experience

Tenure : 12 to 14 Y Years of experience in relevant field 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).

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