Associate Technical Project Manager - Pharmaceutical Manufacturing
Based in Basildon - This is a full time permanent position
We have an opportunity for a capable project manager to help project manage the transfer of technology and manufacturing processes from our client's current manufacturer to alternative sites in the UK. Reporting to the Senior Technical Project Manager you will provide technical advice and support on manufacturing issues and manage quality and technical agreements with partner organisations.
- Develop project plans, in conjunction with other 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
- Generation, review and technically approval of technical documentation
- Ensure compliance in technology transfer and process changes with EU GMP.
- Resolve technical and quality issues including unforeseen deviations relating to the production and testing of products by 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 suppliers and secondary manufacturers.
- Assist when required, in technical due diligence and support in relation to the acquisition of new products, licences and dossiers.
Our ideal candidate will have:
- A minimum of 3 to 5 years' experience in a technical role (production/technical support in manufacturing / packaging).
- Experience in pharmaceutical production or support, ideally with technical transfer of pharmaceutical products.
- Experience in pharmaceutical product analysis.
- Proven experience in technical transfer or analytical method transfer and ongoing laboratory support.
- An understanding of the batch Certification and Conformance process and the issues that can arise during manufacture.
By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.