Require Assistant Manager Production, QA Officer at Medley Pharmaceuticals Ltd
Medley Pharmaceuticals Ltd is a progressive WHOGMP certified; besides approved by several other countries and one of the fastest growing company amongst the top 35 pharmaceutical companies In the country as per IMS.
Assistant Manager Production (API)-Tarapur / Production Officer (API). Tarapur
Experience : 7-12 yrs
Qualification : B.Pharm / B.Sc / M.Pharm / M.Sc
1. Responsible for monthly production planning, Execution & monitoring.
2. Responsible for all daily operation and production of commercial API.
3. To train all shift supervisor and operators about unit operations, safety and SOP.
4. Technology transfer coordinator jointly with R&D & QA.
5. Handle production QMS documents like Change control, Deviations, OOS.
6. Responsible for regulatory audits & customer’s audit CAPA & Implementation of CAPAs.
7. Overall Responsible for Production related SOP, review and implementation at site.
8. Conducting training for new recruited production chemist in terms of cGMP/ GDP aspects and Safety aspects.
QA Officer (Tarapur)
Experience : 4-8 yrs
Qualification : B.Pharm / B.Sc
1. To maintain and control an overall quality management system documentation.
2. Responsible for the preparation planning, coordination and execution of QA training programme. Assessment of other departments training
3. Issuance of batch number, batch manufacturing record, Register, SOP’s, format, protocols, Analytical protocols to departments
4. To review the Analytical records, Batch manufacturing record and batch packing record
5. Preparation of QA-SOP’s, Validation protocol aPQR, summary reports based on the Analytical results and Batch documents data.
6. To coordinate for the validation activities with other department for successful completion
7. Submit customer questionnaire along with declarations, management of free samples.
8. Maintaining vendor approval process
9. Daily assessment of site to ensure GMP compliance level of site through round. 10. Management of regulatory and customer audit at site
11. Management of Deviation, Incident. Change control, OOS, Recall, Market complaint, Investigation, CAPA, Risk assessment etc
12. Interpretation of sales order and overall management of dispatch
13. Reviewing stability data and sharing inference with management.
14. Providing data to Regulatory patent or any other authorities.
If you are looking forward to have a career with Medley, you may explore our current opportunities or send us your resume for openings at firstname.lastname@example.org
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube