We have an exciting opportunity to work within a dynamic R&D department of a large pharmaceutical manufacturer based in Folkestone, where you will be responsible for the coordination of all activities related to the post-launch maintenance of products.
The Key Responsibilities of the role are as follows;
- Lead the product development activities related to post product launch maintenance, business continuity projects such as qualification of alternative manufacturing sites, raw material sources & packaging components.
- Define and conduct the product development that are required to support the qualification for the product change according to local, global quality and regulatory standards with the input of the relevant teams.
- Work with R&D process and manufacturing team to qualify process changes by understanding key process inputs and outputs.
- Test method development: ensure relevant test methods are in place to support product and process change qualification.
- Testing: manage the planning and execution of studies-in house and liaise with external partners if the study is outsourced.
- Documentation: Write and review product development plans, verification and validation protocols and reports
- Design to Manufacturing Transfer: Responsible for the completion of the design transfer activities ensuring all SMEs provide adequate verification & validation reports from successful product transfer to plant.
- Establish effective working relationships internally with other functions including supply chain, procurement, safety, quality and regulatory as well as externally with strategic partners (3rd party manufacturers, raw material suppliers, external laboratories)
- Be aware of the Medical Device Regulation and other relevant local registration and its requirements.
- Be aware of confidential and quality technical agreements and their application to suppliers.
- Provide proper communication about project progress to the project team/PMO on a regular basis.
- Be aware of potential quality issues and provide technical assistance.
You must have the following skills and experience for the role;
- Degree educated
- Proven industry experience in Pharma or FMCG products including formulation and testing.
- Excellent communication skills
- Ability to lead cross functionally, forge strong working relationships and build effective project teams.
- Self-motivated with the ability to plan ahead and use initiative.
- Excellent IT skills - particularly Microsoft software - with the ability to present. information in forms, tables and spread sheets.
- Self-motivated with the ability to plan ahead and use initiative.
- Proactive solutions and problem-solving abilities
The hours of work are 8.00am - 4.30pm Monday to Thursday and 8.00am - 3.30pm Friday. This is a long term temporary assignment with an immediate start
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