Validation Microbiology Team Leader -Stability-Hants-£26k-£30k

5 days left

Cranleigh Scientific
£26000.00 - £30000.00 per annum
12 Oct 2016
02 Nov 2016
Contract Type
Validation Microbiology Team Leader -Stability-Hants-£26k-£30k A global biotech organisation is seeking an experienced Validation and Stability Team Leader to join its Hampshire site. You will manage the workload of 3 microbiology technicians, leading all stability and validation operations. You will be an experienced microbiologist, ideally with prior supervisory experience. You must have experience of product stability validation. Position Summary: To organise the product stability testing programme for specified MBD products, intermediates, third party products, new and redeveloped products. To lead the laboratory team of bench scientists responsible for all laboratory work associated with product validation and product evaluation. To review validation data and produce reports for both internal and customer use. To manage product evaluation projects. To review validation data and advise manager of all necessary actions. To plan and manage the team in line with agreed budgets and goals. Responsibilities To manage and develop the stability programme for MBD products, reporting project information and progress to the Quality Manager. To prepare Compliance SOPs and product testing protocols in accordance with customer requirements (internal and external) regulatory guidelines and company requirements. Carry out the testing programme using protocols in accordance with regulatory guidelines and company requirements. To organise and undertake additional product validation and product evaluation as required To alert manager of potential product issues and assist in corrective actions where required. To monitor team performance against plan and take action where target could be missed. Act as main contact for product specific validation enquiries for the business. Provide validation reports for internal and external customers Prepare validation plan with stakeholders, Prepared Media Sites and ensure that they are informed of progress. Ensure effective communication and liaison with Export Regional Managers regarding product registration. Carry out customer site visits when required by Sales team. Provide validation expertise to product risk assessment process. Manage storage of products under required conditions and ensure that the correct conditions are maintained throughout storage period and that accurate records are kept. Assist in audits and clearing non conformities. Manage Compliance deviation process for specified product groups. To manage team including performance reviews with assistance from Validation Manager. To undertake training of new and existing personnel as required. To fulfil the responsibilities of the position as defined in the Health, Safety and Environmental policies and associated Codes of Practice. To actively promote Health & Safety awareness of all other employees and to help maintain a safe working environment. Minimum Requirements/Qualifications: Must be educated to minimum of a BSc in a Microbiology related subject Proven experience in Microbiology laboratory preferable expertise in Culture Media. Experience of product stability validation. Team management experience. Good planning skills. Willingness to travel where required. Good working knowledge of Word, Excel and SAP. Good communication skills with all levels within the business This job was originally posted as