Highlights:

Skills:Pharmaceutical Quality Assurance and Regulatory Affairs, cGMP, Quality Control, Quality Management, Formulation Science, Pharmaceutical Quality Assurance, Pharmaceutical

Quality Assurance and Regulatory Affairs Manager 10/2012 - current
Sparsh Bio-Tech Pvt Ltd, Jamnagar, Gujarat India
Industry: Pharmaceutical
My job responsibilities are to ensure that cGMP requirements are fulfilled from Vendor or Supplier selection, material procurement till product dispatch
Responsible for the Batch release for sale after reviewing the Batch Manufacturing & Packaging Records, In process Quality Control data & Finished product analysis data.Responsible to approve & authorize the system for review, approval, distribution, revision and destruction of SOPs and controlled documents.Preparation of SOP & check list for releasing or rejecting finished goods. Responsible for the review and approval of key documents such as Quality Manual, Annual Product Quality Review, Batch manufacturing and Packaging records, Process Validation, Analytical Method Validations, Equipment Qualifications, Validation Master Plan, Stability Reports etc.Responsible for handling of Market complains, Product recalls, Change controls, Deviations and Out of specifications etc. Responsible for the approval of Artworks. Responsible for coordination and execution of the internal audit program.Responsible for the planning, review and approval of equipment qualification and validation protocols & reports. Responsible for the planning & monitoring of all calibrations and validations as per Validation Master Plan. Responsible for the Implementation and compliance with the cGMP requirements from Material receipt till product dispatch. Responsible for monitoring of In-process Quality assurance activities. Responsible for conducting G.M.P. Trainings as per the training calendar. Responsible for Co-ordination between Production, Quality Control laboratory and Warehouse. Responsible for the establishment of Preliminary Vendor Selection and Vendor Approval Procedures. Responsible for establishment & implementation of Quality Risk Management throughout the product life cycle from raw materials receipt till product dispatch & also during the distribution in case of new products. Successfully participated & represented the organisation in many audits like WHO GMP, STATE GMP, NDA - UGANDA, MOH - DR CONGO, FMHACA - ETHIOPIA, FDA - GHANA, NMPB - SUDAN, NAFDAC – NIGERIA, TFDA - TANZANIA, PPB – KENYA, PMPB - MALAWI and many Vendor Audits. Responsible for Applications for Product Permissions, COPPs and Free Sale Certificates. Responsible for the Manufacturing License and WHO GMP renewal applications and related documentation. Responsible for Export NOC applications and applications, Product Registration Dossier as per CTD and ACTD Guidelines--
Quality Assurance Executive 01/2011 - 10/2012
Maps Laboratories Pvt Ltd, Morbi, Gujarat India
Industry: Pharmaceutical
My duties were to adopt and implement cGMP through the Organisation to ensure products manufactured are of the quality suitable for their intended use.
Preparation, review and approval of SOPS. Preparation of various validation protocols i.e. Process Validation, Method Validation and Cleaning Validation etc. Issuance of BMR & BPR. Preparation of Site Master File and review of Drug Master File etc. To perform line clearance check and in process quality assurance checks. To involve in batch release procedures. Preparation of Master Validation and Calibration Plan and execution of all validations' & calibrations' activities accordingly. New Product and Additional Product registration in FDCA. To carry out self-inspection and quality audits. Participated in WHO GMP and many vendor audits. Made application for WHO GMP & Manufacturing License renewal.--
Quality Control Officer 10/2010 - 10/2011
Bristol Laboratories Ltd, Luton, Bedfordshire United Kingdom
Industry: Pharmaceutical
Involved in routine Quality Control Activities like Sampling, Analysis and Documentation.
To carry out quality control tests on finished Products, raw materials and in- process generic dosage forms using HPLC, UV and FTIR such as, % Assay, Content uniformity, Drug identification using FTIR, Related Substances (impurities). To carry out dissolution test for tablets and capsules by USP I & II apparatuses. To check the physical parameters such as Friability, Uniformity of weight, Uniformity of dosage units, Hardness, Dimensions, Loss on drying and Disintegration. Water content by Karl-Fisher method, Calibration of instruments, maintaining records, preparing COA and reporting to QC manager. To make sure GLP is maintained in the laboratory. To review batch processing documents and SOP's. To carry out sampling & testing during process validation activities. To prepare and validate method of analysis. Method validations and stability studies. Responsible for the sampling of products for QC Analysis. Responsible for maintaining the product inward and outward register. To carry out In process quality assurance testing at predefined frequency. Responsible for review & compilation of Batch Production Records along with Batch Analytical documents for the final review by Qualified Person before batch release. Participated in MHRA audit.--

Rajiv Gandhi University of Health sciences 09/2001 - 09/2005
Mangalore, Karnataka, India
Degree: Bachelor's Degree
Major:Pharmacy
Pharmaceutics, Medicinal chemistry, Biochemistry, Microbiology, Advanced industrial pharmacy, Pharmaceutical technology, Pharmaceutical organic and inorganic chemistry, Total quality management, Pharmaceutical analysis and Pharmacology.

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