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Job Description

JOB BACKGROUND

Experienced Pharmaceutical Analytical Professional in Method Development, Analysis and Method Transfer.

JOB PURPOSE

To manage activities associated with Technology Transfer (T/T) related to Testing of Drug Substance, Drug Products and Excipient etc from current Contract Manufacturing Site of Drug Product (CMO), Contract Testing Site of Drug product and Stability Study (CTL) and Drug Substance Manufacturing Site (API – manufacturer) to the alternative CMO’s / CTL’s.
To Provide Technical Advice and support on Analytical Testing Issues related to existing products and potential products
KEY ACCOUNTABILITIES

Progress Deliverables are being completed within the base lined time scales
Cost Deliverables are being completed within the base lined 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 (Analytical Related to DS / DP / Excipient) including but not limited to

Project Management and Co-ordination with CMO / CTL / API – Manufacturer for generation of various T/T documentations
Review of the T/T documentations
Approval of T/T documentations
Direct / In-direct supervising of T/T activity
Trouble shooting and CAPA implementation during T/T where required
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, Specifications, Validation Reports
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 development of alternative Method of analysis and also sourcing of Contract Testing Laboratories
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

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