33 Injectable Jobs - Page 2

Diploma / B.E - Mechanical Engineer with 3 to 4 years of experience in installation, commissioning & servicing of pharmaceutical machinery such as: Liquid, Ointment Manufacturing Plants, Liquid Bottle Filling Machines, Capping & Labelling Machines. Required Candidate profile Willingness & readiness to travel domestically & internationally for site visits. Conduct FAT (Factory Acceptance Testing) at vendor sites as per customer specifications & company standards. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

FD of Injectable Products like solutions, Lyo Products, suspension and complex products like iron collids, Peptide and should be familiar with advance analytical characterization. Literature search of new product, conduct pre formulation studies Required Candidate profile Ability of carry out investigations, trouble shooting exercise Exp- 6-8years if Mpharma & 2-3years if PHD

Strategic: Work towards continues improvements in automation & instrumentation to bring down the cost and technology advancement. Plant upgradation works planning, execution on Periodical basis. Able to visualize & plan the activity related to overall Project execution. Plan & execute the work towards the management goals. Able to handle DS and DP equipment’s Updated & aware of GAMP5, cGMP, statutory guidelines & standards requirements for automation and instrumentation. Plan for implementation of Automation layers Aware & update the latest software related to Automation & Instrumentation, DP, DS. Operational: Monitor the overall activity of Automation and Instrumentation activities. Plant level Automation and instrumentation breakdown diagnostics and maintenance for DP, DS, QC, EMS, BMS & Utilities. Support to Automation Layers implementation and validation. Calibration management including planning, execution, documentation and control for the plant level. Automation to support for upstream and downstream processing of MAbs/therapeutic proteins such as microbial, cell culture, chromatography, TFF, blast freezing, CIP/ SIP etc. Technical site support for CCTV, Access control, Door interlock. However main responsibility of maintaining & trouble shooting, planning & execution rests with facility management department. Coordinate with EHS team for trouble shooting of Fire alarm, PAS, VESDA & Gas suppression system. Technical site support for IT team for Data & Internet connectivity. However, main responsibility of maintaining & trouble shooting, planning & execution rests with IT department. Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc. Coordination with user departments & plan for Preventive/Breakdown/ Calibration maintenance. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. And Coordination with user departments & plan for Preventive/Breakdown maintenance. Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. Support Audit & follow Statutory Compliance. Review & approval of P & ID along with control & function layout drawings and electrical drawings. Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. Monitoring of outcome agency for plant operation. Review & coordinate for finalization of agreements. Preparation and execution of QMS documents in the department. Goal setting to team members & annual review. Providing the same to the department head for review & approval. People: Shift scheduling, Manpower planning, reporting & Shift operations. Contract / Service provider Manpower/activities planning, reporting.

Diploma / B.E - Mechanical Engineer with 3 to 4 years of experience in installation, commissioning & servicing of pharmaceutical machinery such as: Liquid, Ointment Manufacturing Plants, Liquid Bottle Filling Machines, Capping & Labelling Machines. Required Candidate profile Willingness & readiness to travel domestically & internationally for site visits. Conduct FAT (Factory Acceptance Testing) at vendor sites as per customer specifications & company standards. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Diploma / B.E - Mechanical / Electrical / EC / IC Engineer with 1 to 4 years of experience in Pharma Machinery Manufacturing Industry as Service Engineer. Conduct commissioning tests to ensure proper setup & functionality. Knowledge in Documentation. Required Candidate profile Machine trial test in factory. Involvement in FAT & trial. Ready for field work till project hand over. Complete Machine installation at site. Machine handover to customer at site. Good Communication. Perks and benefits Negotiable - Depending Upon Candidate & Experience

MJ Biopharm has two manufacturing locations . Our Facility located in Taloja, near Mumbai, is WHO GMP Certified, state-of-the-art facility . Other facility Facility is in Pune