Senior Manager, Corporate Quality Microbiology and Sterile Manufacturing
The world’s largest pharmaceuticals market is also the biggest market for Sun Pharma. We have been present in the US since 1996, working with the country’s healthcare system with a focus on generics, branded generics and over-the-counter (OTC) products. We are valued suppliers to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers. Being a vertically integrated company with a global presence, we have the flexibility to develop and manufacture products in the US as well as at other locations across the world. Our US headquarters is located in Cranbury, New Jersey and we have manufacturing, distribution and customer service teams at multiple locations across the country.
IND123
Job Description:
The position is responsible for providing technical and quality support related to microbiology and sterile manufacturing to all sites in the region. This position also works with local sites in the region to ensure the sterile manufacturing and microbiology facilities, processes and utilities are qualified and meet the current regulatory requirements and standards. Assist in troubleshooting of day to day problems, investigations, and CAPA activities. The job holder is required to participate in internal and external audits function as microbiology and sterile SME . This position will involve approximately 20% – 25% domestic and international travel.
Key Responsibilities:
Provide expert technical and quality support in microbiology, aseptic manufacturing, validation, new technologies, and sterilization
Assist the sites in the troubleshooting of day to day problems related to microbiology and sterile manufacturing which are escalated to regional office and interact with site management to address critical quality and compliance issues.
Standardize and harmonize all applicable standards, procedures and practices related to microbiology, aseptic manufacturing, environmental monitoring and contamination control.
Ensure compliance of the processes, procedures, and practices with existing standards, policies and procedures.
Support in regulatory inspection preparation, audit support, audit response and remediation strategy, including regional quality actions and risk assessments across the region.
Support sites in microbiology and sterility assurance related investigations, CAPA activities and implementation of corrective actions. Perform gap analysis to plan actions for continuous improvements.
Other responsibilites as assigned or required.
Requirements:
Minimum Bachelor of Science (Microbiology, Life Science). Preferred Master of Science and/or PhD.
Requirements:
Minimum 10 years of experience within the pharmaceutical and/or biotechnology industries
Expertise within Quality Control/Quality Assurance in Microbiology/Sterile Operation
Skills within Sterile Manufacturing and Product Development
Thorough knowledge of contamination control, disinfection, cleanroom design and operation, aseptic techniques.
Proven problem solving abilities. Works on unusually complex problems and provides solutions which are highly innovative.
Working knowledge of applicable cGMP regulations (21 CFR 211, EU GMP, PIC/s GMP, ICH etc.) and standards (ISO).
Experience with SAP, Trackwise (or similar product), MS Word, MS Excel.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to handle and feel and talk and hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, push, lift, turn, bend, a nd perform repetitive motion.
Must be capable of bending and lifting, moving and/or carrying up to 50 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have the ability to travel internationally and domestically for this role as needed, approximately 20% – 25%.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.
