Vital Healthcare

About Vital Healthcare

Job Summary Responsibilities of the Quality Unit Manager : It’s very important to have a clear understanding of the regulatory responsibilities of the Quality Unit and to ensure that those responsibilities are effectively executed to establish an effective system to prevent product quality and CGMP compliance problems. 1. To establish the quality system a. Establish the quality management system to describe how the firm complies CGMPs and operates to maintain a state of control b. Keep current with good industry practices, and applicable to the mission of your operation. 2. To audit compliance to the quality system a. Audit for compliance to policies and procedures: on paper vs. practice b. Report on the performance of the quality system, including trends, that help decision making for targeted actions 3. To establish procedures and specifications a. Ensure that procedures and specifications are appropriate and followed b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services (contract manufacturing, contract laboratories, etc.) 4. To establish manufacturing controls a. Ensure that appropriate manufacturing in-process controls are implemented b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory 5. To perform laboratory tests or examinations a. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications b. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions 6. To review and approve or reject all things CGMP a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents b. Review and approve/reject reprocessing and rework procedures c. Review and approve/reject production batch records and make the final decision to release a product lot into commerce. 7. To ensure investigation of nonconformance a. Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes b. Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected 8. To keep management informed a. Report on product, process and system risks—and keep management informed b. Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed 9. To describe responsibilities in writing a. Have a complete and compliant procedure that describes responsibilities b. Follow the procedure 10. To remain independent a. Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities b. Be independent reviewer and approver with respect to manufacturing and process/ product development units Job Type / Category We are WHO-GMP , ISO 9001: 2015 Certified finished formulation manufacturer and exporter at Nashik, Maharashtra. We manufacture Injections (Liquid & Dry Powder), Ointments (Sterile &Topical), Eye/Ear/Nasal Drops, We Export to Nigeria, Tanzania, Kenya , Sudan, Cote-De-Ivory and other African countries. We have a strong presents in Srilanka , Papua New Guinea, and some countries of central America and Latin America. Required Education, Skills and Qualifications Candidate should be M.Pharm/ B. Pharm or M.Sc ( Micro/ Chemistry ). Minimum 12 to 15 years of experience Must be very fluent in English, must have good shop floor work experience of parenteral prouducts in production and quality control departments. Must be very strong in Quality management system Must have faced many national and international inspections Must be energetic, enthusiastic and ready to take challenges, to achieve the goal Benefits Medical benefits, bonus, Pf/Esic etc. Job Type: Full-time Salary: ₹1,200,000.00 to ₹1,500,000.00 /year Job Type: Full-time Salary: ₹1,200,000.00 to ₹1,500,000.00 /year Experience: total work: 10 years (Preferred) Licence: FDA approvals in production or Q.c deparment.. (Preferred) Benefits: Phone / Internet reimbursement Health insurance Provident fund (PF) Paid leaves / Leave encashment Industry: Pharmacy

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