SME Sterile Manufacturing

SUN PHARMA; Panchmahal District; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

Sun Pharma seeks an SME for Sterile Manufacturing in Mumbai/Vadodara with 18+ years of experience in sterile operations. You will oversee liquid product manufacturing, complex injectables, and associated CIP/SIP equipment, ensuring GMP-compliant processes and documentation.

Key duties include leading qualification activities (URS, IQ, OQ, PQ), preparing batch records, and managing QMS elements (CAPA, deviations). Travel 40-50% is expected.

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum 18+ years of experience in sterile manufacturing.
• Experience with GMP, qualification protocols, and equipment like CIP/SIP skids.
• Willingness to travel 40-50%.

Responsibilities

• Operate and supervise sterile manufacturing processes and equipment.
• Perform and document line clearance, cleaning, sanitization, batch manufacturing.
• Prepare qualification protocols (URS, IQ, OQ, PQ) and SOPs.
• Maintain QMS documents (CAPA, deviation, change control) and coordinate with vendors.

Skills

Sterile manufacturing

GMP compliance

Process equipment operation

Documentation & QA

Education

Bachelor’s degree

Job description

Job Description:

Title: SME Sterile Manufacturing

Location: Mumbai / Vadodara

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.”

JOB DESCRIPTION:

Following are the key requirements:

1. Expertise in operation of below process and equipment’s:
   • To handle manufacturing area.
   • To handle process like manufacturing of liquid product including media, complex injectable and suspension manufacturing.
   • To handle the process equipment in manufacturing like manufacturing skid, filtration skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment’s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester etc.
2. Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
3. Handling and recording of procedure like line clearance, area cleaning and sanitization, batch manufacturing and filtration etc.
4. Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
5. To prepare of new standard operating procedure for process and equipment’s.
6. Experience for preparation of batch manufacturing records.
7. To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
8. To handle communication with vendor and procurement team on procurement to design parts of new equipment’s.
9. To ensure compliance to cGMP and documentation for various production activities.
10. Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.

Travel Estimate

40-50%

Job Requirements

Educational Qualification: Bachelor’s degree

Experience: 18+ years’ experience in sterile manufacturing

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).