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Pensions Project Specialist
3 weeks ago
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
You will be expected to provide the technical support for executing new product commercialisation projects (scale-up) from Dechra PD (Product Development).
The role will also require you to provide the technical support for executing optimisation projects for currently approved products from site or from other internal sites or from CMOs (Contract Manufacturing Organisations) using product lifecycle approach, and to aide with the technical support for troubleshooting current commercialised products; Support the Technical Manager and represent the department on project team level.
Execution of product commercialisation projects for the site (NPI and post approval changes). This will require close collaboration with Product Development, Production and QA groups on NPIs using product lifecycle approach, preparation and approval of GMP documentations to support such projects, scheduling, raw material acquisition, supervising engineering batch manufacture, etc.
Identifying potential process improvements for existing commercial products including proposals for formulation / process optimisation. Then support implementation of changes after management approval.
Assist in activities for successful transfer of new equipment to production, including training of both supervisors and operators.
Using the Product lifecycle approach and statistics, take project leadership for the technical activities involve in the commercialisation of internal products. Assist in the Technical assessment of products / projects (development and commercialised products for optimisation/site transfer).
Assist in implementing the product life cycle program for the site to ensure compliance with Dechra's commercialisation standards and compliance with current Global Regulatory expectations.
Proactively identify and troubleshoot formulation and process type issues of products manufactured internally to improve product quality and to minimize product supply interruptions.
Degree in life sciences, engineering, pharmaceutics, chemistry, or similar fields.
Relevant work experience combined with technical knowledge, problem solving skills, sound understanding of process validation and verification, and the ability to plan and co-ordinate multiple activities.
This individual should be able to make competent scientific recommendations.
Minimum of 5 years of industrial experience in the pharmaceutical or related industry, or an equivalent combination of education and experience with knowledge of pertinent Regulatory and Industry guidance's and regulations.
Has demonstrated the ability to design, develop and implement effective technical transfer and product lifecycle strategies for the dosage forms manufactured by the site (solids, liquids, gels, terminal sterilisation) and a firm working knowledge of manufacturing platforms and pharmaceutical facility infrastructure.
Hands-on' knowledge of pharmaceutical manufacturing equipment, and ability to supervise bath manufacture and instruct production operators would be beneficial.
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