We have a new opportunity available for an Analytical Cleaning Validation Manager to join our growing R&D team. Reporting directly to the Head of R&D, this role will manage and oversee the development, validation, and ongoing implementation of all analytical cleaning methods, ensuring consistency with company policies and regulatory requirements.
Responsibilities of this role will include:
- Oversight for all procedures related to the toxicity assessment & residue control of compounds being introduced to the EirGen Campus.
- Manage derivation of ADE & OEL assessments of all compounds across the Campus.
- Ensure suitable technical review and risk based strategies are maintained and actions taken by relevant departments to maintain compliance.
- In conjunction with relevant managers ensure alignment of approaches for cleaning across the Campus manufacturing areas, including OSD & FF.
- Oversee development of analytical methods & detergent procedures.
- Oversee analytical validation execution for new molecules introduced to R&D and Sterile Operations, with support & guidance provided as required for established molecules.
- Provide technical advice to manufacturing area owners on cleaning related activities and advise on steps necessary to ensure compliance standards are maintained.
- Provide training and mentoring to the team as well as other departments as necessary to accomplish the goals of the program.
- Oversee the introduction of new products into the facility from an analytical cleaning validation perspective and work cross-functionally to determine appropriate cleaning verification/ validation acceptance criteria.
- Work to identify efficiencies and continuous improvement projects in the cleaning verification/ validation program.
- Work to stay informed of industry regulatory changes as it applies to cleaning validation and apply lessons learned to drive value within the organization.
- Review and revise the Cleaning Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
- To work closely with the ASM and TSM to ensure seamless transition of methods from development to validation
- Ensure contemporaneous collection of relevant data for R&D Tax Credit claim purposes
- Assist the Head of R&D in achieving company goals
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Recruit, train, manage and develop the R&D analytical team.
- To ensure change is delivered as specified by the Head of R&D and to perform additional tasks as agreed to support effective running of the business.
- To raise CAPAs and work with relevant departments to ensure completion
Health & Safety
- Ensure requirements of EirGen’s Safety Statement are implemented.
- Continuously promote a positive safety culture by leading by example.
- Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
- Report any defects.
The ideal candidate for this role will meet the following criteria:
- Qualified to a minimum of degree level in science discipline with a post-graduate qualification advantageous.
- At least 3 years supervisory/ management experience in a pharmaceutical laboratory.
- Excellent knowledge HPLC method development and validation.
- Extensive previous experience of regulatory inspections.
- Excellent understanding of current industry guidance and regulatory requirements for cleaning validation programs.
- Strong understanding of pharmaceutical manufacturing facility operations.
- Cross-functional collaboration and leadership capabilities required to drive delivery of cleaning validation program across Campus GLP and GMP expert.