Associate Technical Manager
A leading pharmaceutical company is advertising a vacancy for an Associate Technical Manager for their office in the UK. The organisation prides itself on its portfolio of global mature branded medicines which are acquired, developed, and marketed to over 130 markets internationally. This is an exciting opportunity to bring real skill and expertise to an established and prestigious company.
- 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, that appropriate data is generated.
- Report issues/deviations from plan, costs, strategies timings, and progress.
- Generate, negotiate, and approve the Quality and Technical Agreements between the company and its partner Contract Manufacturing Organisation.
- Oversee the generation, review, and technical approval of Technical documentation, including, but not restricted to, Protocols, Manufacturing and Packaging Batch Manufacturing Records, and 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 the 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 and secondary manufacturers.
- Assist, when required, in technical Due Diligence and provide support in relation to the acquisition of new products, licences and/or dossiers.
Skills and Requirements:
- A degree in life sciences.
- A minimum of 2 to 3 years' experience in a technical role (Production/Technical support at a manufacturing/packaging and possibly Quality).
- Technical knowledge of all solid, semi-solid and liquid pharmaceutical dosage forms. Technical knowledge on Sterile dosage forms is also desirable.
- Experience in Pharmaceutical Production or support, with a proven experience in Technical Transfer of Pharmaceutical products and production, is desirable but not essential based on the production skills demonstrated with evidence.
- An understanding of the batch Certification and Conformance process and the issues that can arise during manufacture that can affect the final release.
- Able to use all applicable software systems, databases etc. including documentation management systems.
- A comprehensive understanding of Quality Compliance within the EU in addition to USA and Canada.
- A good understanding of Gxp (including cGMP and cGDP).
- Able to write and review complex Pharmaceutical documentation and generate when required accurate summaries.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Marjolene D'Almeida-Ayeni at +44 203 854 2626 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.