Technical Manager Formulations

Job Description

Job Opening Details back to list Reference Code: FormTecMgr0221Baroda Job Title: Technical Manager Formulations Category: Pharmaceuticals, Hospitals / CRO, Bio Technology & Life Science About company: Leading fast-growing Pharma company having offices in India, UK, Asutralia, Middle East & Europe.Job title : Technical Manager Formulations (Vadodara Location)Department : TechnicalReports to : MS / KG JOB BACKGROUND :Experienced Pharmaceutical Formulation Professional in Drug Product Development and ManufacturingJOB PURPOSE : To manage activities associated with Technology Transfer (T/T) related to Manufacturing of Drug Products from their current Contract Manufacturing Site (CMO) to the alternative CMO s. To Provide Technical Advice and Support on issued related to Manufacturing of Existing products and Potential productsKEY ACCOUNTABILITIES : Progress Deliverables are being completed within the baselined time scales Cost Deliverables are being completed within the baselined cost plan Quality Deliverables are being completed to defined expectations, first time Reporting Regular and timely reporting of project progress to the sponsors Risk To proactively manage foreseen project risk, mitigating as necessary Change Managing changes to the project without unduly affecting stated objectives and benefits Performance Progress is being earned for the expected cost Regulatory All required statutory and regulatory conditions are being met MAIN RESPONSIBILITIES & DUTIES :Team member during T/T activities (Formulation Related) including but not limited to a. Project Management and Co-ordination with CMO / CTL for generation of various T/T documentations b. Review of the T/T documentations c. Approval of T/T documentations d. Direct / In-direct supervising of T/T activity e. Trouble shooting and CAPA implementation during T/T where requiredf. Providing information to Internal Stake holders eg Regulatory affairs for filing necessary variations KEY TASKS & RESPONSIBILITIES : Develop Project Plans, in conjunction with other relevant parties, in relation to product site transfers or new product development projects, to include timescales, costs and identifiable risks Manage and implement agreed project plans in accordance with the product licences and GMP Guidelines Ensure that issues are identified within the project are resolved, timelines are met and where necessary, appropriate data generated Report issues / deviations from plan, costs, strategies timings and progress Generate, negotiate and see through to approval the Quality and Technical Agreements between Atnahs and its partner Contract Manufacturing Organisation Generation, review and technically approval of Technical documentation including but not restricted to Protocols, Manufacturing and Packaging Batch Manufacturing Records, Validation Reports, Specifications, Tooling Drawings. Ensure compliance in Technology Transfer and Process Changes with EU GMP under the supervision of a nominated Qualified Person (QP) Resolve Technical and Quality issues including unforeseen deviations relating to the production and testing of products by Contract Manufacturers and Testing Laboratories. Report issues to the QP who is responsible for releasing these products to the market Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products Work with Regulatory, as part of a multidisciplinary team, regarding new and existing licence applications or variations Assist in sourcing alternative API suppliers, Drug Product, Primary and Secondary manufacturers Assist when required, in technical Due Diligence and support in relation to the acquisition of new products, licences and / or dossiers Any other task as assigned based on requirement of organisation. PERFORMANCE STANDARDS : To deliver agreed objectives within an agreed timeframe To maintain professional standards at all times To be punctual, maintain dress standards, be polite and courteous to internal and external customers at all times To act in an efficient and professional manner at all times Maintaining a high level of confidentiality, as appropriate to the circumstances Be approachable, helpful and flexible in attitude at all times Any other task as assigned based on requirement of organisation. CTC: No bar for right candidate Key Skills: Technology Transfer (T/T) Experience Pharmaceutical Drug Product Development OSDPharmaceutical Manufacturing OSDPharmaceutical Drug Product Validation & Technology Transfer OSDPrimary & Secondary Packaging of Drug ProductsPharmaceutical Project ManagementDrug Product Development Other Dosage Forms Drug Product Manufacturing Other Dosage FormsDrug Substance & Drug Product AnalysisAnalytical Method Development & ValidationEU cGMP Eudralex Vol 4Hands-on Experience in Development, Manufacturing & Packaging of OSDICH Q1, Q2, Q6 A & B, Q7, Q8, Q9, Q10, Q12, Q14, Regulatory Variations Requirements (EU)Analytical Method Transfer / Verification / ValidationProcess Validation & Continues Process Verification Location: Vadodara/Baroda Required Experience: 10-15 yrs Positions: 1 Contact Person: Hitesh Vaghela Email ID: db@tercpl.com Qualification: M.Sc,B.Sc,B.Pharm,

Keyskills :
high level of confidentialityproject managementcustomer relationsjavanew product developmentanalytical method developmentdeliveryagilestatements of work sow