Junior Manager in Quality Control, Pharmaceutical industry Resume
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Resume:
Seeking a job profile which would enhance my strengths and helps in rediscovering my abilities.
Summary
- Over . years of experience in Quality Control and Assurance in reputed Pharma Industries.
- Having extensive exposure in Quality Control Systems.
- Good at team management with strategic thinking.
- Thorough in Documentation and Procedures.
- Demonstrated abilities in achieving and meeting the targets.
- A keen strategist and planner with skills in conceptualizing and developing processes.
- Meticulous and good at juggling multiple tasks and working under pressure.
- Result oriented, versatile, with management skills & strong analytical, problem-solving abilities.
- Safety consciousness in the day to day job activities.
- Excellent communicator, a quick learner with an analytical bent of mind& ability to lead and build a team.
- Have exposure to Laboratory Information Management System &#;LIMS&#;
- Have some exposure to Regulatory Affairs (RA)
- Preparation of Product specifications
Core Competencies
Quality Control
- Analysis of Active Pharmaceutical Ingredient (API), finished goods, Intermediates and Stability samples.
- Establishing of Stability studies and Procedures
- Hold time study for validation of batches and New API products.
- Documentation and review of test results as per good manufacturing practices (GMP).
- Maintaining of standards viz: Working Standards, Impurity Standards etc.
- Maintaining of documentation in line with Food and Drug Administration (FDA)
- Handling of analytical and test instruments.
- Maintaining of documents in line with International Council for Harmonisation (ICH).
Quality Assurance
- Qualified Lead Auditor in Quality Management System ISO - from Intertek.
- Training of new recruits towards job orientation.
- Verification of documents for submission to various clients.
- Evaluate the Root cause of Out of Specification (OOS) and Out of Trend (OOT).
- Investigate, report and review of Incidences/Deviations and all non-conformances.
- Review of analytical documents, change controls and annual product review.
- Qualify and management of standards
Employment Profile
Dr. Reddy’s Laboratories as Junior Manager-Quality Control
May’- Feb’
DRL is one of the largest Pharmaceutical Company of repute in the country catering to both domestic and overseas market. It is a company acting with dynamism to bring good health, leveraging technology to provide good health to all, with a small step towards robust healthcare system.
- Oversaw the entire gamut of Quality control of the team.
- Strategizing workflow to the deadlines with timely approval of the products.
- Providing analytical support for regulatory queries.
- Review reports for SAP entries.
- Expertise in the use and Calibration of instruments like FTIR, UV Spectrophotometer, Polarimeter, KF Autotitrator, Potentiometer, Ph meter, Melting point apparatus, particle size instrument, Coulometer, etc..
- Provide Certificate of Approval and Analysis of the products to customers.
- Worked on LIMS project for creating modules, User Requirement Specification creation, and module approval
- Creating specifications for LIMS
- Good exposure to USFDA and customer audits.
- Evaluation of root cause for OOS and OOT reported in coordination with the investigation team.
- Wet analysis – solubility, heavy metals, ROI, LOD
- Inter-department co-ordination w.r.t. QC.
Biocon Ltd. as Sr. Executive – Quality Control
July’-April’
Biocon Ltd is a leading Pharmaceutical renown globally and providing healthcare globally, under a dynamic leadership.
- Analysis of API finished goods, intermediates and stability samples
- Strategizing workflow to meet the deadlines with timely approval of the products.
- Providing analytical support for regulatory queries.
- Documenting, reporting, review of laboratory test results as per GMP.
- Expertise in the use of instruments like FTIR, UV Spectrophotometer, Polarimeter, KF Auto-titrator, Potentiometer, pH meter, Melting point apparatus, particle size instrument, Coulometer, HPLC, UHPLC, GC, etc..
- Provide Certificate of Approval and Analysis of the products to customers.
- Review of all analytical documents, change controls and annual product review
- Good exposure to USFDA and customer audits.
- Evaluation of root cause for OOS and OOT reported in coordination with the investigation team.
- Wet analysis – solubility, heavy metals, ROI, LOD
- Inter-department co-ordination w.r.t. QC.
- Preparation of specification and stability study protocol
- Documentation of calibration records, temperature and humidity records etc.
- Joined as a fresher, imbibed professional knowledge, gained working experience in the Quality department as an Analyst. In general, gained experience in the overall functioning of the Pharmaceutical industry.
Scholastics
Lead Auditor ISO - QMS Intertek
Master of Science (Analytical Chemistry St. Joseph’s College Bangalore
Bachelor of Science (Chemistry) Meenakshi College for Women
Chennai
Personal Vitae
Date of Birth: th December
Languages: English, Hindi, Kannada, Tamil & Telugu, French (Beginner)
