Highlights:

Skills:

Manager Quality Assurance 08/2013 - current
Pfizer India, Chennai, Tamilnadu India
Industry: Pharmaceutical
Microbiology post graduate with over 13 years 8 months of experience covering Quality control and assurance Microbiology in the Pharmaceutical sector. Keen administrator with recognized proficiency in managing Pharmaceutical Microbiology lab and quality monitoring of sterile products. · Knowledge of FDA regulations, ICH and global regulatory requirements. · Equipped with Strong communication and presentation skills with excellent analytical and problem solving skills to support and achieve goals.
Serves as the Subject Matter Expert (Microbiology) technical, quality and compliance issues. · Serves as Quality Assurance Lead for ANDA / 505(b)(2) projects. · Co-ordinate with project team for · Supporting to initial evaluation of API and qualification of API. · Review of API supplier MET / Sterility / BET documents for methods. · Review of sterilization validation for TS products and Filter validation documents during formulation development stage. · Micro method validation requirements for in-process and FP. · Product Quality Assurance · Review and approval of change control, deviation report, OOS & investigation report generated at CMO and review and manage implementation of CAPA. · Review and approval of Lot dispositions, Annual Product Quality Review generated at CMO. · Co-ordinate with audit team for Sterility Assurance Assessment. · Co-ordinate with cross functional team and the partners for the critical requirements. · Review of 3.2.P.3.5 part process validation and /or evaluation for regulatory submission. · Maintain current knowledge of relevant regulations. · Ensure effective planning, tracking, archiving of activities, especially product release, internal memos and key correspondence. · Provide professional, responsive and co-operative service at all times. · Undertake other duties as assigned by the Quality Head.--