Shiny K

Experienced in cGMP, Good Laboratory Practices and FDA regulations. Excellent communication skills, both oral and written and willingness to work in a team environment. Excellent interpersonal skills, flexibility in work, attention to detail. Able to work in fast paced environment with accuracy.

Quality Assurance specialist - Trafa Pharmaceutical Inc. - Richmond, Canada

(2022-10)

• Prepared all quality related documents on the company letter heads not only including COAs, COOs, Vegan statements, Non-GMO statement, allergen checklists, Halal certificated and Kosher certificates
• Providing all required COAs and related documents to the Order processing to ensure timely processing of the orders
• Worked with purchasing to ensure that all raw materials vendors are approved and ensure all raw materials received are within specifications
• Worked with third party testing labs to arrange testing for raw materials and document all samples/ results and prepare/ approve COAs based on the test results
• Assisted purchasing with quality related queries while coordinating with manufacturers
• Coordinate with manufacturers on documentation and ensure all incoming raw ingredients have supporting COAs, statements and certificates
• Provide both the third-party lab and the customers with the MOAs of the raw materials required by coordinating with the manufacturer
• Issued client sample requests and making sure the required samples are sent and re send if any additional sample when required
• Ensure all documentation provided to the customers is logged and is up to date
• Answer all customer queries about the raw materials related to quality and send any documents as requested by coordinating with the manufacturer

Production administrator - PNP Pharmaceuticals - Burnaby, Canada

(2019-09 - 2022-10)

• To ensure the completion of MBRs and PBRs by reviewing for GMP/GDP Compliance
• Identifying and analyzing issues related to in process manufacturing and resolving them
• Generate change control as needed for master formula revisions and involved in editing the MFs
• Ensuring the completion of all GMP documentation in a timely manner
• Participating in non-conformance investigation
• Involved in reviewing and approving deviations, CAPAs and OOS investigations
• To ensure that the production personnel are adhering to GMP regulations and manufacturing of products is carried out following FDA regulations
• Maintaining raw material Reconciliation and production statistics for month end reporting

Quality Assurance Specialist - Gland Pharma - Visakhapatnam, Andhra Pradesh, INDIA

(2014-09 - 2018-12)

• To provide training, guidance and floor support to Manufacturing & Engineering (M&E) staff in regards to compliance and quality systems
• Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
• Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Non-Conformance and CAPAs
• Ensured that GxP quality documents are process controlled to ensure compliance, such as logbook, batch records, and standard operating procedures
• Ensured review and release of batch records, approval of manufacturing order, shop floor order, EURs and CURs in cGMP and GDP compliance
• Initiation and approval of NCs (Class II & I). Also, assisted in CAPA, implementation of preventive maintenance programs and work orders to assist with deviation management
• Successfully assisted in investigating root causes and impact assessment. Also, looked into OOS, OOT
• Compiled reports, spreadsheets and necessary documentation for regulatory support, and preparation of Annual Product Quality Review (APQR)
• Worked along with the manufacturing team regarding the review and documentation of raw materials from the vendor which need QA approval, in case of faulty or rejected materials

MS - Pharmacy with major in pharmacology - GITAM University

BS - Pharmacy - Andhra University