Quality Control Microbiology Lab
Resume:
S Ramasubramanian
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Contact No: +91-725*******, (Mobile)
**************@**********.***
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Currently working as Manager QC Microbiologist with IP Pharmaceuticals
India Private Limited (Subsidiary of Pfizer Inc), Bangalore.
OVERVIEW
. Microbiology post graduate with over 10 years of experience covering
Quality control and assurance Microbiology in the Pharmaceutical
sector.
. Keen administrator with recognized proficiency in managing
Microbiology lab and quality monitoring of sterile products.
. Knowledge of FDA regulations, ICH and global regulatory requirements.
. Experienced in Microbiology lab setup, sterilizer (steam and dry heat)
validation, Aseptic area qualification, Aseptic Process Simulation,
Incubator validation, Microbiology analytical method validation,
Environmental monitoring and Water system monitoring.
. Well versed in microbiology documents review, Quality Management
System handling of deviation, change control, CAPA, customer complaint
and OOS.
. Proven track record of strong leadership, planning and project
management skills; ability to lead cross-functional teams ensuring
strict adherence to timelines and quality as per the project goals.
. Equipped with Strong communication and presentation skills with
excellent analytical and problem solving skills to support and achieve
goals.
CAREER SCAN
Since Aug'13:
IP Pharmaceuticals India Pvt. Ltd., (Subsidiary of Pfizer Inc) Bangalore
Manager QC Microbiologist
Role:
. Serves as the Subject Matter Expert technical, quality and
compliance issues.
. Review of Microbiological Analysis reports and method validation
reports.
. Critical review of EM data and documentation for accuracy for the
data generate at CMOs.
. Interact and coordinate with contract manufacturers for
documentation requirements.
. Oversee microbiology activity at India office.
. Review of Analytical documents for projects outsources at CMO/
Analytical Laboratories.
. Co-ordinate with cross functional team and the partners for the
critical requirements.
. Review and release of the commercial batches.
. Review of the master batch record.
. Review and approval of change control, deviation report, OOS &
investigation report generated at CMO and review and manage
implementation of CAPA.
. 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.
Sep' 12 to Jul 13:
Sequent Scientifics Limited, Bangalore
Assistant Manager, Quality Control Microbiology Department
Jul' 11 to Sep' 12:
SGS Lifescience India Private Limited, Chennai
Sr. Executive, Quality Assurance Department
Role:
. Review of Microbiology analytical documents.
. Handling of Quality Management System as per ISO17025.
. Handling of customer audits and submission of compliance report of
any of the non-compliance served by audit.
Nov' 09 to Apr' 11:
Strides Arcolabs Limited, Bangalore
Sr. Executive, Quality Control Microbiology Department
Role:
. Method Validation of MLT, Sterility, BET and Assay.
. Review of analytical data sheet (finished product, raw materials,
trend data of aseptic area monitoring and water monitoring).
Jan' 07 to Nov' 09:
USV Limited, Daman
Executive, Quality Control Microbiology Department
Role:
. Establishment of Microbiology lab (Appropriate instrument,
equipment qualification and its documentation).
. Calibration and Validation of Microbiological Equipment as per
validation schedule.
. SOP, Protocol and Specification preparation.
Jan' 04 to Jan' 07:
Sitec Labs Private Limited, Mumbai
Management Staff
Role:
. Environmental monitoring of aseptic area and purified water / WFI /
Pure steam system monitoring.
. Microbial Limit Test of RM, IP and FP.
. Sterility Test by conventional and close system.
. Bacterial Endotoxin Test by gel clot method.
. Disinfectant efficacy test.
TRAININS ATTENDED
1. Risk Management in Aseptic Processing.
2. "ISO 17025 - Internal Auditor" Training.
3. Pharmaceutical Drug Stability by USP.
4. Introduction to Pharmaceutical Process filtration by Merck Millipore
ACADEMIA
Exam University/institute Year Class/Divisio Overall % of
passed n Marks
M. Sc., Sri Paramakalyani 2003 Ist 64%
Microbiology College,
M S University,
Tirunelveli
B. Sc., S C K College, 2001 Ist 68%
Biochemistry M S University,
Tirunelveli
IT Forte:
Office Package: Microsoft Word, Microsoft Excel, Microsoft PowerPoint,
Microsoft Outlook Express.
PERSONAL DETAILS
Name : S Ramasubramanian
Gender : Male
Date of Birth : 20-May-1981
Marital Status : Married
Language Known : Tamil, Hindi and English
Current Salary : 9.90 Lacs / Annum
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