Manager QC at Mepro Pharmaceuticals Pvt. Ltd. (2015-12 – Present)
Presently working at Mepro Pharmaceuticals Pvt. Ltd. Surendranagar, Gujarat (Formulation Unit). Reporting To: Head QC. Audits Faced: UNICEF, EUGMP, WHO Geneva and other customer audits.
- Planning the analysis of In-process/ Finished product/Process validation samples and ensure release of material / batches within the time.
- Ensure effective implementation of system and procedures as per GLP, GMP and other regulatory requirements.
- Review of analytical data, reports, protocols generated in QC laboratory.
- Monitor and ensure online documentation during analysis.
- Review of Specification and Test procedures of inprocess/ Finished product.
- Preparation/ review of SOP's in QC department.
- Ensure Good documentation practices followed in QC department.
- Ensure that all the instrument/ equipment's are in good working condition and timely completion of AMC's.
- Ensure proper operation, Calibration and maintenance of all QC instruments as per schedule.
- Manage stocks of chemicals, glassware, chromatography columns & instrument spares as required.
- Ensure Qualification of analyst, qualification of working standard and instrument/ equipment's are done on time as per SOP.
- Ensure availability of chemicals, reference standards, impurity standards and other consumables.
- Investigate OOS /OOT results in Finish products, Stability, Raw material, packing material.
- Investigate incidents, deviations in laboratory and prepare investigation report.
- Initiate change control and CAPA whenever required.
- Ensure 21-CFR part 11, Data integrity and QMS system is followed in laboratory and its continuous improvement.
- Preparation of monthly projects in the Server system.
- Review pendency of work and it's management.
- Review and approval of all calibration records of instruments/ equipment's in laboratory.
- Coordination with other departments like Regulatory, QA, production and stores for necessary requirements.
- Internal and external audits and its compliance.
- Ensure audit trial are checked & online review of data done in the server based system for correctness.
- Review of COA of Finish product / Raw material/ Packing material.
- Ensure water analysis and EM are performed as per set standards.
- Maintain smooth and safe working environment in the laboratory.
- Monitor the team performance and guide them to achieve the set goals.
- Training to new and existing persons on system, SOP's and any other regulatory aspects or guideline whenever required.
- Providing data to customers and regulatory agencies as per requirement.
- Any other work assigned by management.
Senior Executive at Flamingo Pharmaceuticals Limited (2013-04 – 2015-12)
Worked as a raw material section incharge. Reporting To: Manager QC. Audits Faced: USFDA, MHRA and customer audits.
- Responsible for work planning of raw materials, excipients and release as per requirement on time.
- Responsible for Good documentation practice and follow up for sample analysis and release to meet production requirements.
- Responsible for preparation & review of documents in raw material section for its complete and correctness before release.
- Preparation of COA and entry of material release in SAP.
- Responsible for preparation of Specification / Standard test procedures and Test data sheets of raw material & excipient.
- Responsible for method transfer activity, chromatography and investigations.
- Responsible for trouble shooting of instruments during any analysis of raw material section.
- Responsible for online documentation by analysts.
- Responsible for investigating incidents, OOS and preparing the related documents and CAPA.
- Ensure smooth working in the section by following written procedures.
- Training to all the analyst in raw material section and other laboratory analysts whenever required.
- Ensure good condition of laboratory all the time and work in a compliant way.
- Communication with R & D regarding method related issues and its rectification.
- Giving answers of queries of auditors during audits if required.
- Supporting to other sections related to any analysis or document review.
- Handling the SAP QM module for any requisitions or preparation of masters and release of materials.
Senior Officer at Ranbaxy Labs Limited (2006-11 – 2013-04)
Reporting To: Sr. Executive
- Analysis of Finished products and Stability.
- Responsible for calibration and maintenance of QC instruments.
- Online documentation.
- Stability chamber management i.e. sample keeping and withdrawal as per planner.
- Temperature monitoring of stability chambers and its documentation.
Officer at Lupin Limited (2005-10 – 2006-10)
Reporting To: Sr. Executive
- Analysis of In process & Finished products.
- Responsible for calibration and maintenance of QC instruments.
- Online documentation.
- To keep the lab in good condition.
Jr. Officer at Glenmark Pharmaceuticals Ltd (2003-07 – 2005-09)
Reporting To: Sr. Executive
- Analysis of In process & Finished products by chemical and GC.
- Responsible for calibration and maintenance of QC instruments.
- Online documentation.
- To keep the lab in good condition.
