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Phone: PHONE NUMBER AVAILABLE ~ E-Mail: EMAIL AVAILABLESENIOR LEVEL REGULATORY AFFAIRS PROFESSIONALStrategic Planning | Regulatory Documentation/Operations | Pharma Product Registration | Team ManagementWork authorization: Legally allowed to work in United States (Green Card)Profile SnapshotA dynamic professional with rich experience in Pharma Industry in the domain of Strategic Planning, Stability and validation programmes, IPQC, Regulatory Documentation/Operations, Quality Compliance, Pharma Product Registration, Liaising & Coordination, Drug Registration and Team Management.Expertise in responding to all product complaints and queries. Adept at searching and retrieving clinical and nonclinical studies. Expertise in analysing technical documents before submitting to internal customers. Efficient in ensuring compliance with company, state and federal requirements for all performed work Exceptional communication, collaboration & team building skills with proficiency at grasping new technical concepts quickly and utilize the same in a productive manner.Skills Set Strategic Planning Stability and validation programme IPQA Drug Registration Liaising and coordination Team management Regulatory complianceEmployment detailsAug. 2021 till dateQuality Assurance SupervisorUSPL NutritionalsJob Responsibilities Monitoring production rooms logbooks Pharmacy room / production room clearance Dispensing of Raw Materials Review BPRs Checking AQL samples and giving decision on further processing Checking shipment documents and approving the same for shipments Sampling and release of packaging materialsMar. 2021 Jul. 2021Quality Assurance SupervisorVitaCare ParmaJob Responsibilities Monitoring production rooms log books Pharmacy room clearance Dispensing of Raw Materials Reconciliation of Raw Materials / Inventory cards archiving Process Deviation initiation Review BPRs Solving production QA related issues Weekly calibration of scales/balances Monthly calibration Weekly temperature/humidity chart check and change Monthly temperature/humidity record check Change control initiation Packaging components/labels inventory card reconciliation/archive Weekly GMP auditApr. 2019 Mar. 2021Quality Assurance InspectorVitaCare Pharma Assuring quality of products by Performing and monitoring all production floor QA related functions for the manufacturing process for solid dosage (tablets and hard gelatin capsules) Performing and carrying out all the QA related functions required as per established company standard and procedures and assure that manufacturing/production is according to cGMP regulation Logbook maintenance on daily and calendar basis Providing required approval for production activity and make appropriate entries in respective batch manufacturing records/MMR Verifying raw material and components prior to usage as required and checking and monitoring the dispensing/weighing process. Checking the cleanliness and providing usage approval of equipment and production rooms in the production department viz. granulation, compression, encapsulation and packaging. Collecting granulation, tablet, capsule and packaging samples at various stages of production. Performing and collecting in-process samples e.g. for individual blend samples for uniformity, and composite samples and submit it for QC testing. Perform Hardness, AQL, DT, friability and thickness testing of tablets Providing approvals for the setup of machines and commencement of production. Assisting packaging operation whenever required Calibrating instruments weekly Preparing status labels
Jan. 2019 Apr. 2019Regulatory Affairs SupervisorReliance Vitamins LLC Developing labels of dietary supplements as per FDA norms Collaborate with suppliers for documents Applying for certifications like Non-GMO , Organic etc. Organizing internal and external documents
Jan. 2018 Aug. 2018Head Regulatory AffairsPuniska Healthcare Private Limited, Ahmedabad, India Getting manufacturing licenses from local drug authority for products meant for development purpose Getting import licenses for APIs and RLDs for product development Help R & D team with regulatory requirementsJul. 2006 Dec. 2017Senior Manager Regulatory AffairsAculife Healthcare Private Limited (Previously known as Nirma Limited), Ahmedabad, India Guiding team of executives (14 direct reports) in preparing dossiers for submission to LATAM countries, SE Asia, Africa, Francophone countries and CIS Understanding of CTD filings Liaising and coordination Managing regulatory audits Regulatory compliance Coordinate / Support the audit function for vendors, suppliers Coordinate / Support the communication of the audit schedule and executing to plan as required by local procedures and regulatory requirements. Support in external audits; provide written reports and observations in a timely manner and assure correctives are adequate and timely. Participate / Coordinate in internal audits. Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments. Assist and participate in regulatory inspection activities as required. Work with site personnel to ensure completion of all regulatory commitments. Support maintenance of central file for correctives and inspection history. Coordinate / Support the approval process for new vendors / materials.Clean room experience Experience in area monitoring, air sampling Obtains feedback from employees and Quality Assurance regarding the production of various products to ensure that the product is being produced at acceptable levels of quality Communicate effectively with others orally Assist the Validation and Maintenance staff with the operation and execution of engineering projects Train employees and demonstrate production tasks to assist new employees to learn correct production proceduresProducts handled I V Fluids Anaesthetics Plasma Volume Expanders Parenteral nutritionAlso worked in capacities ofMedical RepresentativeSales and Marketing ExecutivePharmacistCompanies worked withKopran Chemical Company, Mumbai, IndiaChemech Laboratories, IndiaPharmacistAl-Badiya Pharmacy, Doha, State of Qatar Setting up pharmacy Catering to doctors prescriptions Maintaining inventory Customer servicePharmcistMazoon Pharmacy, Muscat, Sultanate of Oman Setting up pharmacy Catering to doctors prescriptions Maintaining inventory Customer serviceAcademicsB. Pharm., L M College of Pharmacy, Ahmedabad, IndiaLanguage proficiency : English, Hindi, Gujarati |
