Role & responsibilities Minimum 10 to 15 years of experience in pharma industry. Candidate should be well versed with Progen ERP software, Track N trace software, Cyber security, IT risk management, Network administration, IT Infrastructure management & Security devices like sophos firewall, End to End security, Linux operating systems, Windows server operating system & acronis backup solution. Candidates should have good exposure in documentation like SOP preparation and support for CSV & Qualification. Preferred candidate profile Reputed Pharma background
Role & responsibilities Minimum 3 to 5 years experience of handling IT infrastructure and networking. Candidates should have good knowledge of user support, handling of wifi routers, switches, firewall, windows operating system & and maintaining backup logs. Preferred candidate profile
Role & responsibilities 3-5 years of experience in sourcing and procurement of Packaging Materials, for Pharmaceutical industry. The position will be accountable for the entire procurement process of packaging material. Sourcing Vendor development, Price negotiation and procurement. The position is based at Mumbai - Sakinaka. Graduates with strong techno-commercial knowledge from reputed pharma background will be preferred. Preferred candidate profile Pharma Background
Role & responsibilities Minimum 3 to 5 years experience of handling IT infrastructure and networking candidates should have good knowledge of user support, handling of wifi routers, switches, firewall, windows operating system & and maintaining backup logs. Preferred candidate profile Pharma background
Role & responsibilities Purchase Executive / Assistant Manager for Pharma Company Atleast 4-8 years exposure to Capex & Consumable (Engg. Spare parts, Laboratory Chemicals & Regents, Columns Reference standards, working standards & impurity standards) etc.. Negotiation with vendor for pricing & delivery timelines Purchase Order preparation and follow up for deliveries. Negotiations & execution of AMC with vendors for capital equipment of Plant, QC & EHS dept. Weekly & Monthly reports for POs & PRs. Co-ordination with cross functional team viz. Engg, Production, QC & QA Preferred candidate profile Candidates preferred form reputed pharma background
Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background
Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.
Role & responsibilities 1. Overall responsible For HVAC operation and maintenance. 2. Responsible for utility operation and maintenance. 3. Responsible for OMS documents related to Engineering. 4. Responsible for any other work assigned by Head Engineering 5. Responsible for building maintenance planning and execution. 6. Responsible for To maintain preventive maintenance and break down maintenance records. 7. Responsible to attend all breakdowns. 8. Responsible for monitoring & controlling of EMS system. 9. Responsible for ensure compliance of engineering SOPs and other SOP as per quality system. 10. Responsibility for maintain documents as per cGMP & GDP. 11. Responsible for all types of breakdown for various machineries in non-sterile area. 12. Responsible for operation & maintenance of RO-EDI water plant. 13. Overall responsible for New machine installation IQ, OQ, PQ with Require service qualification. 14. Responsible for operation & maintenance of injectable water plant. 15. Overall responsible for new machine installation IQ, OQ, PQ with required service qualification. 16. Responsible for calibration & validation of all equipment/instrument. 17. Overall responsible for preventive maintenance record of the machineries or plant. 18. Responsible for training planning & execution. Preferred candidate profile Reputed Pharma background
Role & responsibilities 1. To maintain all the documents as per SOP & cGMP. 2. Handling of QMS activities like change control, deviation, CAPA and QRM of production department. 3. Planning and execution of department trainings as and when required / Training of personnel on department SOP. 4. Market complaints investigation of products manufactured at Agio Pharmaceutical Limited and ensuring completeness of CAPA. 5. To ensure the completeness of investigation & compliance of market complaints for injection department. 6. Ensure the implementation of current regulatory requirements at injection department as applicable. 7. Preparation of Standard Operating Procedures at injection department. 8. To perform job assigned by Department Head as and when required. 9. Online in-process entry & create batch order in ERP system. 10. Generate purchase request in ERP system. Preferred candidate profile Reputed Pharma Background
Role & responsibilities Minimum 10 to 15 years of experience in pharma industry. Candidate should be well versed with Progen ERP software, Track N trace software, Cyber security, IT risk management, Network administration, IT Infrastructure management & Security devices like sophos firewall, End to End security, Linux operating systems, Windows server operating system & acronis backup solution. Candidates should have good exposure in documentation like SOP preparation and support for CSV & Qualification. Preferred candidate profile Reputed Pharma background
Role & responsibilities 1.Responsible to maintain the record for the sterile and non-sterile area machineries. 2. Responsible for maintaining all history card of for sterile and non-sterile area. 3. Responsible for all types of breakdown for various machineries in for sterile and non-sterile area. 4. Responsible for all new machine installation & its engineering services. 5. Responsible for all audit related compliance of for sterile and non-sterile area. 6.Responsible for putting the requirement of required spares and rectification of breakdown machineries in for sterile and non-sterile area. 7. Responsible for factory premises maintenance planning and execution. 8. Responsible to ensure compline of engineering SOPs and other SOP as per quality system. 9. Responsible for QMS documents related to engineering. 10. Responsible to maintain documents as per cGMP & GDP. Responsible for continuous upgradation of facilities, equipment and system for production of high 11.quality product. 12 Responsible for project planning and execution. Responsible for utility operation and maintenance (HVAC, water system, Boiler, DG and Air 13.compressor) 14. Responsible for new machine installation IQ, OQ, PQ with requires service qualification. 15. Responsible for all equipment preventive maintenance & breakdown maintenance. 16. Responsible for Calibration & Validation of all equipment/instrument. Responsible to maintain the record for the sterile and non-sterile area machineries. 2. Responsible for maintaining all history card of for sterile and non-sterile area. 3. Responsible for all types of breakdown for various machineries in for sterile and non-sterile area. 4. Responsible for all new machine installation & its engineering services. 5. Responsible for all audit related compliance of for sterile and non-sterile area. Responsible for putting the requirement of required spares and rectification of breakdown 6. machineries in for sterile and non-sterile area. 7. Responsible for factory premises maintenance planning and execution. 8. Responsible to ensure compline of engineering SOPs and other SOP as per quality system. 9. Responsible for QMS documents related to engineering. 10. Responsible to maintain documents as per cGMP & GDP. Responsible for continuous upgradation of facilities, equipment and system for production of high 11.quality product. 12 Responsible for project planning and execution. Responsible for utility operation and maintenance (HVAC, water system, Boiler, DG and Air 13.compressor) 14. Responsible for new machine installation IQ, OQ, PQ with requires service qualification. 15. Responsible for all equipment preventive maintenance & breakdown maintenance. 16. Responsible for Calibration & Validation of all equipment/instrument. Preferred candidate profile Reputed Pharma background
Role & responsibilities Job Responsibilities: 1.Market samples receiving, entry and stock maintenance. 2.List updations, equipment and SOPs, Product code list updation 3.RM BOM preparation and checking of new product solid, liquid and semi-solid dosage form. 4.Preparation of MFR/MPR/PDR of solid, liquid and semi-solid, injectable dosage form. 5.Sample upkeep Withdrawal and Storage of Sample. 6.RA related mail communication, document follow ups, preparation and send as per urgency and priority of documents. 7.List updations (RM/PM/Stability samples)/ Innovator samples/ Equipments. 8.BOP preparation and corresponding mail correspondence. Responsible for QMS activity ,MFR preparation and corresponding change control documentation. 9.Document preparation as per regulatory requirement and commercial MFR preparation and revision with change control. 10.BMR/BPR filling as per dossier requirement/ Dossier related documentation 11.Filing of documents and list updation. 12.Commercial Work Order Request form entry & Clearance. 13.Audit related documentation 14.New item code creation 15.Change control initiation for new product development & tech transfer Preferred candidate profile Reputed Pharma background
Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with other team members to help with the process. Preferred candidate profile : Reputed Pharma background only