Bela Patel Email & Phone Number

Brampton, On, Ca

Milton, Ontario, Canada

• Perform product releases, perform Quality and Regulatory reviews on imported products, making quality decisions and addressing or resolving problems based on analysis and consultation with clients.• Support product Launch activities. Provide Quality Assurance guidance and support to potential new clients or new products.• Managing customer complaints: Receiving and triage of customer complaints, analyzing customer complaints and identifying trends and tendencies based on investigations and trend analysis.• Maintaining Master Documents- coordinate with clients for receipt, review and updates to Master Documents to ensure compliance to GMP’s and related to product release activities.• Maintain and review in-house and client based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports.• Management of Change Controls: support the initiation of change requests for equipment, primary and secondary components, processed, systems and documentation, following up on the request and closing changes upon implementation. Managing trend reports for the changes.• Management of Deviations and CAPA: Investigate and document any discrepancies recorded during product handling and ensure product disposition decisions are made in conjunction with client and GMP regulations.• Provide support during audits/ inspections by internal, client, third party or regulatory bodies.• Provide support for product recalls including customer notifications, coordination of customer returns and maintaining documentation.• Support the QA department in ensuring Innomar GMP facilities operate and are in compliance with GMPs and allocable Health Canada Regulations.

Milton, Ontario, Canada

• Receipt and inspect client specific products • Investigate and document any discrepancies recorded during product handling and ensure product disposition decisions are made in conjunction with client and GMP regulations.• Maintains data integrity of the inventory management systems through precisely accounting for applicable material transactions• Assisting the Innomar Quality Assurance staff with the labeling and sampling of product, which may involve operating material handling equipment (i.e. Reach truck and pump truck)• Assists Quality Assurance staff with maintenance of the facility temperature monitoring process• Management of retain samples and retain area• Verify returns which are processed by return’s department and passing QA for eligible returns• Proceed created OSDs (overage, shortage, & damage) and forward to client for disposition• Implementation of Corrective Actions and Preventative Actions• GMP & Regulatory Compliance• Ensuring all sensitive products outlined by Innomar’s SOPs are handled accordingly and in an expedited manner• Undergo regular training on Good Manufacturing Practices• Trained and understand the operation of Innomar’s WMS and related software and be able to function within the system• Trained and function using Innomar’s TMS software to ship product samplesAQPIC:• Must be on the premises while all transactions involving narcotic and controlledsubstances are conducted. Transactions include receiving a drug, shipping a drug, and any time the cage, vault, or storage room is open.• Ensure that all sales of narcotic, controlled and/or restricted drugs, are made only to those authorized under the “Controlled Drugs and Substances Act” and its regulations to purchase such drugs.• Ensure that all labels are following the labeling requirements.• Supervising activities with respect to narcotics and controlled substances and ensuring that those activities comply with the Regulations.

Milton, Ontario

•Responsible for ensuring returns are processed as per established timelines •Quarantining of product as relating to all inbound receipts and returns as outlined by SOPs•Maintaining and developing relationships with numerous clients and suppliers in order to return products due to order errors, concealed damages, expiry, or recalls•Logging and verifying all in bound shipments for material identity, quantity and any shipping damage when receiving the product •Coordinates any receiving inspections within established receiving protocols, inputting all inbound receipts in the Innomar WMS (Sage) software and filling out corresponding documents •Completing stock put away utilizing MHE •Ensuring that all documentation is completed accurately, including preparing shipping documentation, i.e. waybills, dangerous goods IATA paperwork and customs papers•Managing inventory movement in a FIFO or FEFO manner (first-in-first-out, first-expiry-first-out) through a safe and organized efficient flow of properly identified and segregated goods through the warehouse • Well versed in understanding, navigating and utilizing Sage Version 6• Collaborating with management and department heads in regards to UAT script writing and testing related to Sage Version 12•Assisting the Warehouse Supervisor, Inventory Coordinator or Innomar Quality Assurance staff with the handling of released product •Assists Quality Assurance staff with maintenance of the facility temperature monitoring process •Processing with QC sampling activities and providing the sampling documents to clients/foreign sites as per their requirements under QA assist•Production assembly and supplies management, i.e. refrigerated box assembly and frozen handling, supply kitting activities •Implementation of Corrective Actions and Preventative Actions •GMP & Regulatory Compliance•Protocol adherence•Performed duties according to SOP’s, GMP’s and all other standards and company policies

Toronto, Ontario, Canada

•Assisted and performed routine procedures and followed written instructions (SOPs, batch records, protocols, etc.) to support manufacturing intermediate, bulk or final drug product to meet FDA regulatory quality requirements•Completed documentations as per SOP’s, GMP’s such as observations, batch information, etc•Dismantled, cleaned and sanitized and assembled processing equipment according to established SOPs to ensure GMP compliance and productivity goal•Operated all required equipment and machinery for store, clean and transport production•Completed reliability sheet documentation accurately and in a timely manner•Ensured the proper selection, care and use of tools, parts and equipment while performing job related duties•Participated in the line clearance process•Collected in-process samples for Quality assurance measurements•Performed other related duties as assigned•Contributed in team work and other team related activities

Patan, India

•Processed prescriptions and dispensed medications•Received orders and supplied wholesale drugs to satellite pharmacies•Handled patient and staff inquiries either by phone or online•Maintained legal records as per regulating guidelines•Maintained inventory of drugs on hand and records results•Prepared billing information for medications

Patan, India

•Review receiving documents, data logger report and other associated documents and send to client•Release quarantine/quality hold product in accordance with client instructions and regulatory•Responsible for following up on investigations, non-conformance, Deviations, CAPAs to ensure closure and author compliance investigations•Review, sign-off, and file applicable QA records including certificates of destruction, preventive maintenance records, pest control records, sanitation records, calibration records, and packaging records•Monitor temperature conditions within the facility•Respond to Client QA-related inquiries and requests

Post Graduate In Diploma, Quality Assurance And Quality Control

Activities and Societies: •Audited production plant for GMP compliance and documented audit report •Compiled SOPs for pharmaceutical.

Masters Of Science, Inorganic Chemistry

Advanced study of Inorganic Chemistry

Bachelor'S Degree, Chemistry

Study of Chemistry and Botany, Laboratory studies of Inorganic, Organic and Physical Chemistry

Diploma, Pharmacy

Activities and Societies: Biochemistry, Chemistry, Pharmaceutics, Anatomy and Physiology, Pharmacology, Pharmacy Management