SME Sterile Manufacturing

Sun Pharmaceutical Industries, Inc.; Mumbai, Vadodara; On-site; INR 3,000,000 - 5,200,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a Senior SME in Sterile Manufacturing to lead complex liquid, injectable, and suspension production in a controlled environment. You will operate and qualify sterilization and filtration skids, maintain isolators, and ensure adherence to cGMP and batch documentation.

The role requires extensive experience with UR/DQ/IQ/OQ/PQ, SOP creation, and QMS management, including change controls and CAPA. Collaboration with vendors and procurement is essential.

Qualifications

• 18+ years’ experience in sterile manufacturing.
• Experience with process equipment including CIP/SIP skids and isolators.
• Familiarity with qualification phases (UR, DQ, IQ, OQ, PQ).
• Exposure to QMS documents (change control, CAPA, deviation).
• Knowledge of cGMP and batch documentation.

Responsibilities

• Operate sterile manufacturing processes and equipment in controlled areas.
• Manufacture liquids, complex injectables, and suspensions per SOPs.
• Handle skid-based and filtration equipment; maintain line clearance.
• Prepare qualification protocols for new equipment (UR, DQ, IQ, OQ, PQ).
• Draft new SOPs for processes and equipment; prepare batch records.
• Maintain QMS documentation: change control, CAPA, risk assessments.
• Coordinate with vendors and procurement for parts and tools.
• Ensure compliance with cGMP and production documentation.
• Plan and execute qualification activities with manpower allocation.

Skills

Sterile manufacturing

cGMP compliance

Equipment operation

Qualification protocols

SOP drafting

QMS documentation

Process troubleshooting

Tools

pH meter

DO meter

CIP/SIP skid

Dispensing isolators

Manufacturing isolators

Integrity tester

Job description

Company: Sun Pharmaceutical Industries Ltd

SME Sterile Manufacturing

Key Responsibilities

• 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.
• Exposure to performed filter integrity testing of product filters and air vent filters along with PUPSIT mechanism.
• Handling and recording of procedure like line clearance, area cleaning and sanitization, batch manufacturing and filtration etc.
• Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
• To prepare of new standard operating procedure for process and equipment’s.
• Experience for preparation of batch manufacturing records.
• To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
• To handle communication with vendor and procurement team on procurement to design parts of new equipment’s.
• To ensure compliance to cGMP and documentation for various production activities.
• Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.

Job Type: 40-50%

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).