Highlights:

Skills:Aseptic Manufacturing, QMS, Microbiology, Audit and Compilance

Associate Director Quality 03/2023 - current
Agno Pharma Jiangsu, Lianyuangang, - Select - China
Industry: Pharmaceutical
Associate Director – Sterility Assurance in Agno Pharma Jiangsu, Lianyungang, Jiangsu, China. Managing 2 sites QA and QC.
• Leading Sterility Assurance group and Microbiology Lab with ~30 team members for Aseptic Products (API and Drug Product). • Risk assessment for the Manufacturing process using FMEA tools, gap assessment and compiling Contamination Control Strategy against EU Annex-1 / US FDA guideline requirements. • Management of product release by ? Oversee the review process of batch records and testing documents, release of raw material, excipient, primary packing material, in-process samples, final release and stability reports. ? Oversee conduct of investigation resulting from process deviation, OOS and adverse data trend, Facilitates, participates, reviews, leads and/or approves Investigations, and root cause analysis. • Develops key quality processes, metrics and indicators to measure, trend and improve key quality determinants with respect to product release operations. • Communicate lot disposition pending issues to Vice President, Quality. • Lead quality issue escalation activities, as required. • Interface with Senior Management and responsible individuals to assure task completion on or before established due dates. • Function as the Quality department liaison and subject matter expert to other department representatives, external partners and regulatory representatives. • Review and approval of new facility planning, commissioning and qualification. • Involve in process of recruiting talent and build a high-performance team; mentors and coaches colleagues--
Manager Quality Assurance 08/2013 - 03/2023
Pfizer Inc, Chennai, Tamil Nadu India
Industry: Pharmaceutical
Manager Quality Assurance in Pfizer Products India Pvt Limited, Chennai, India Subject Matter Expert - Microbiology and Aseptic Manufacturing Support
• Serves as Quality Lead and Subject Matter Expert - Microbiology for Sterile Injectable projects. • Review and release of commercial Sterile Products manufactured by Contract manufacturing Organizations. • Handling of Investigations, Deviations, Batch failures, Incidents, OOS and OOT- Review, Evaluation, Follow up, Closing and Implementation • Review of Equipment’s qualification, calibration, and validation data. • Assess the new contractors for Quality Due Diligence, Multi Product Facility Assessment and Sterility Assurance Assessment. • On-boarding and commissioning of green field manufacturing units for Aseptic Manufacturing Operations. • Supplier and contract manufacturing organization qualification and management, Quality Agreement negotiation with Contractors--
Assitant Manager Microbiology 11/2009 - 07/2012
Sequent Scientifics Limited, Bangalore, Karnataka India
Industry: Pharmaceutical
Assistant Manager Microbiology in Sequent Scientifics Limited Managing Microbiology lab activities and commissioning and qualification of New Sterile facility
• Serves as Microbiology Lead for Sterile Injectable projects (API and DP) • Involved in initial lab set-up and regulatory system implementation • Managed the scheduling for environmental monitoring of manufacturing site.--
Executive Microbiology 02/2007 - 11/2009
USV Limited, Daman, Daman and Diu India
Industry: Pharmaceutical
Executive Microbiology
• Supervised Microbiology tests and regular lab activities, commissioning and qualification green field Sterile Drug Product facility. ? EM, Water sampling and microbiological analysis of water samples. Population determination of Biological Indicators. Media preparation, Media suitability tests. Sub culturing, preservation. ? Isolation and identification of microorganisms using Vitek 2 Compact identification system. ? Sterility testing and Bacterial Endotoxin Test of finished products. Participated in process simulation studies. Container Closure Integrity Testing – Microbiological method. ? Preparation of in-house SOPs, qualification of equipment, generation of reports, reviewing of documents--
Management Staff 01/2004 - 01/2007
Sitec Labs Private Limited, Mumbai, Maharastra India
Industry: Pharmaceutical
Management Staff in Microbiology lab
• Execution of Microbiology Analysis as per customer specific procedure. • Involved in initial setup of Microbiology Laboratory--

S Chattanatha Karayalar College 06/1998 - 04/2001
, , India
Degree: Bachelor's Degree
Major:Biochemistry
Minor:Microbiology and Chemistry
Bachelor of Science in Bio chemistry

Login to view resume: Ram -