OBJECTIVE:

To seek a challenging position in an organization where I can put my best efforts, skills to achieve the goals of the organization.

SUMMARY:

Microbiology Team Leader (R&D & Quality control department) in leading pharmaceutical company. More than 10 years of progressive experience and repeated success in developing project initiatives, directing project plans and achieving performance targets.

HIGHLIGHTS:

Organized

Detail-oriented

High sense of urgency

Strong communication skills

Multiple and complex project management

Flexible and versatile in the presence of changing priorities

Cross functional team management

Current Experience: Qatar Pharma, Doha, Qatar. Project Team Leader 08/2013 to Current

Supervising a group of junior microbiologist, trainees & lab assistant, Preparation of validation protocols and validation reports, Updates and highlight quality and safety issues for Microbiology Lab related with USP, BP, and ISO & ICH guidelines, Updating the testing as per recent USP, BP, ISO & ICH guidelines, Stability testing & supporting to microbiological tests to lab management on routine basis, Review and approve test reports log books, data sheets that are generated in micro lab, Review SOPs and Protocols with relevant to QC department, Review compendial and other site and corporate policy changes and ensure necessary change control for lab SOPs, Risk assessment study for microbiology lab and product contamination, Participate in trouble shooting activities for Utility systems and clean rooms, Conduct investigations for OOS and CAPA results, Approve/ Authorize additional testing/ re-testing/ re-sampling as appropriate, based on review of test results, Lab investigation Reports & /or cross functional investigation, Participate in cross functional investigation and other relevant forum to represent Microbiology section, Coordinate in Method Transfer, Validation studies and Method Qualification Studies, Participate / co-ordinate in Internal Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities, Coordinate with Senior Manager in performing periodical appraisal of Microbiologists, Coordinate with Senior Manager in planning and operation of the Department, Oversee the Calibration and Preventive Maintenance Program, Ensure completion of periodic review of SOPs, Promote CI culture in the area to ensure sufficient and objective practices, Supervise and overseas Third Party Contractors, where applicable, Any other tasks as and when assigned by Senior Manager, Coordinate with other department on planning and related testing, Coordinate with vendors, services engineers for equipment validation, calibration and maintenance work, Maintaining lab stock according to requirement, Any other duties as assigned by the Senior Manager / Director

TECHNICAL SKILLS:

Microbial Enumeration test for raw material, finished products, packaging material as per USP, BP, In-house & also by client methods, Sterility testing of sterile finished goods by open method & Closed system, Vitamin assay, Antibiotic assay, Bacterial endotoxin test (gel clot method) method and Chromogenic method, Having knowledge in Tablets, Capsules, Soft gelatin capsule, large volume Parenteral, Small volume Parenteral, Probiotic analysis, syrup, dry powder, ointment, topical drugs, Haemodialysis, dietary supplements, cosmetics, food analysis, packing material analysis, medical devices, Ayurveda products and suppositories, Preservative efficacy test for sterile and non-sterile products, Growth promotion test and self life validation for prepared Medias, Label claim sensitivity study for lysate and count for biological indicators, Environmental monitoring by using settle plate, air sampler, contact plate, particle counting in clean rooms and swab, Validation study for disinfectant, Validation and calibration for various instruments like Autoclave with keye validator, incubators, hot air oven, laminar air flow and bio safety hood, Worked in LIMS Software, ALFIE software, Maintains and handling of Microbial cultures, Gowning qualification of the newly arrived staffs, Sterility method validation, Antibiotic assay method validation, Validation of water system, Filter integrity testing, Container closure integrity

ADDITIONAL TECHNICAL SKILLS:

Packing material analysis and art work checking

FTIR analysis, Dissolution, Disintegration, Chemical analysis, Raw material analysis

AUDITS FACED

USFDA, Jordan FDA, Ministry of Public Health – Qatar, Various customer audits like Dr. Reddys, ABBOT, Baxter- India, ISO 9001: 2008, GCC.

PREVIOUS WORK EXPERIENCE

Sr. Executive Microbiologist: Caplin Point Laboratories Ltd.

May 2011 - Aug 2013, Pondicherry, India

Company profile: Manufacturers of sterile and non-sterile formulations (injectable, dry powders, ointments, creams, capsules, tablets, syrups.)

Executive Microbiologist: Dept. Microbiology SGS India Pvt Ltd

(USFDA, WHO, ISO 9001:2008, NABL APPROVED).

November 2010 to April 2011Company profile: SGS India Pvt. Ltd is an analytical leader worldwide.

Junior Microbiologist: Dept. Microbiology Tablets India Ltd.

July 2006 – October 2010

Company profile: Tablets (India) Ltd. is the manufacturer of injectables by both LVP & SVP, Probiotic, dietary supplements dry powders, ointments, creams, capsules, tablets, syrups, soft gelatin capsules.).

EDUCATIONAL QUALIFICATIONS:

M.Sc. Microbiology with 68 % (Bharathidasan University).

B.Sc. Microbiology with 55 % (Manonmanium Sundernar University).

J. Jayasingh

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