Skill: production , sop , manufacturing , documentation , instrument calibration; Exp: 10-13 years; Responsible for providing Quality Assurance (QA) strategy and support to development and GMP Manufacturing & Testing Operations relative to the production and disposition of development and clinical trial materials . Reviews master and executed batch records, investigations, protocols & reports, SOPs, test methods, change controls, validation documentation, equipment/instrument calibration & validation documentation, and other GMP documentation to ensure compliance with global Board of Health regulations. Serves as a Quality representative and single point of contact on PharmSci Project Team (PSPT) and CoDevelopment (CoDev) teams for biosimilar projects. Based in PBDC Chennai, this position has responsibility for making individual contributions in the day- to-day oversight of Quality Operations Project Teams (PSPT and CoDev). This position requires solid understanding of quality systems as they relate to biologic cell banking, drug substance (DS) and aseptic drug product (DP) manufacturing, testing, and packaging. This position will support biosimilar development projects as well as clinical supplies and Pfizer Global Supply (PGS) transfer activities. Some business travel may be required to other Pfizer sites as well as to contractors, suppliers, and external laboratories used by Pharmaceutical Sciences. Represent Quality Operations (QO) on Research and Development Project Teams. Provide quality leadership and oversight activities to project teams and day to day GMP oversight to development, manufacturing and testing of development materials and clinical supplies. Perform disposition of clinical trial materials (cell banks, DS, and DP). Serve as QA advisor for customer groups for investigations, project issues, SOP interpretations, and regulatory compliance. Communicate with, influence, or negotiate with internal and external customers to ensure resolution of Quality related issues (project teams, Supply Chain, Manufacturing, Regulatory, PGS commercial sites, external Vendors). Drive resolution and alignment on compliance issues with other Quality groups/lines across PharmSci Quality Assurance (PSQA), PGS and vendors. Review and/or approve various development and GMP documents including procedures, batch records, protocols, reports, etc. Advise on policies and procedures, Pfizer Quality Standards, and Board of Healt (BoH) regulations. Contributes to the interpretation of GMPs for the Pharm Sci functional areas. Represent Pharm Sci QO on Right First Time, product lifecycle Risk Assessments and Project Teams. Lead and/or participate on special projects, teams and local or global initiatives such as continuous improvement teams. Interpret and disseminate information about current industry and regulatory trends; advise customer groups on current industry standards and modifications to current systems required to meet these standards. Assist in guiding customers on compliance matters, and develop standards and practices where industry may be leading existing BoH regulations. Provide formal/informal mentoring of Quality Operations colleagues. Conduct training in compliance and regulations Support programs in combination biologic/device platforms. Educational Requirements BS/MS – minimum 10 years technical / scientific / pharmaceutical experience. PhD – minimum 6 years technical / scientific / pharmaceutical experience and relevant Work Experience. Candidate should possess a minimum of 6-12 years of pharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes. In addition, expert knowledge of GMP and regulatory requirements as related to the biological drug development process is required. Experience in biologics and Quality Assurance is desirable. Team player with strong interpersonal, organizational, and communications skills are a must. Candidate must possess sound quality judgement, ability to navigate through complex issues and know when to escalate quality issues in a timely manner. Candidate must have good presentation and report writing skills. The position will report to PSQA team in Lake Forest, USA and will interface with QA colleagues globally. The position will have interaction with Pharm Sci in PBDC, Chennai and Pharm Sci Lake Forest on a routine basis. Individual contributor role. Refer to attached Job Description for Manager Quality Assurance Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Degree: ME/ M.Tech./ MS (Engg/ Sciences)
Function: Production / Maintenance / Service Engg. / Manufacturing / Packaging