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Full-time
bachelor degree, postgraduate degree
Posted 15d ago
Apply by Sep 30
~40 hrs/week
Responsibilities
Lead the design and qualification activities for pharmaceutical process equipment and clean utilities at a new site. Manage QMS documentation, ensure cGMP compliance, and coordinate with vendors and regulatory auditors.
Requirements
Requires a B. Pharmacy or M. Pharmacy degree with 12 to 14 years of relevant experience in the pharmaceutical industry. Must have expertise in qualifying sterile manufacturing equipment and utility systems.
Full job description
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).
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues.
At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come.
With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
Offices: Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN
How many Manufacturing jobs are open in Mumbai City, India right now?
There are currently 264 open manufacturing positions in Mumbai City, India listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Mumbai City, India?
Companies currently hiring include PwC, Accenture, SUN PHARMA, Mondelēz International, Innomotics, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Mumbai City, India?
Yes — 34 of the 264 open manufacturing positions offer remote or hybrid work (5 remote, 29 hybrid).
How do I apply for Manufacturing jobs in Mumbai City, India?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.