SME Sterile Filling

Position Overview

We invite experienced professionals to join Sun Pharma as a Subject Matter Expert (SME) in Sterile Filling, based in Mumbai or Vadodara. This role is pivotal to advancing aseptic processing and quality assurance in our manufacturing operations.

Key Responsibilities

• Operate and manage aseptic and lyophilisation processes, including filtration, filling, lyophilizer loading/unloading, and capping.
• Maintain and troubleshoot critical equipment such as filling machines, capping machines, lyophilizers, filtration skids, isolators, VHP pass boxes, and mobile LAF units.
• Conduct detailed reviews of smoke studies on the filling line, encompassing filtration and aseptic interventions, under static and dynamic conditions, and implement corrective actions when necessary.
• Apply extensive knowledge of aseptic techniques, including media fill simulations, gowning/de-gowning procedures, area cleaning, sanitization protocols, and personnel gowning qualifications.
• Train and upskill operators on filling line processes to ensure high standards of operation.
• Propose and benchmark process upgrades to comply with evolving regulatory requirements.
• Perform filter integrity testing for product and air vent filters and execute PUPSIT protocols.
• Manage procedures related to line clearance and aseptic interventions effectively and provide necessary training.
• Lead qualification activities for new equipment, cleaning, and sanitization processes, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop new Standard Operating Procedures (SOPs) for processes and equipment management.
• Prepare and review batch manufacturing records associated with sterile filling.
• Coordinate communications with vendors and procurement teams regarding design specifications and procurement of new equipment parts.
• Ensure adherence to current Good Manufacturing Practices (cGMP) and maintain thorough documentation of production activities.
• Plan and execute qualification activities efficiently while managing manpower allocation.

Travel Requirements

Up to 40-50% travel may be required for this role.

Educational and Professional Requirements

• Bachelor's degree in a relevant discipline.
• Over 13 years of experience working with manufacturing filling machines and related aseptic processes.

About Sun Pharma

At Sun Pharma, we are committed to your professional growth and success. We foster an environment where you can thrive, lead with confidence, and collaborate as we create a better future together. Your well-being and career development are our priorities.

Disclaimer

This job description reflects the general nature and scope of duties but is not exhaustive. Job responsibilities and qualifications may evolve over time, and the employer reserves the right to assign tasks appropriate to the employee’s expertise and background.