J562765SwindonIS&T Permanent£65,000 to £70,000 per annum - car allowence & bonusFull Time09/10/2018Executive – Site Director IT - Cyber Security IT - Data Warehousing IT - Data Storage
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We are currently looking for a Data Integrity Officer to join a market leading pharmaceutical company based in the Swindon area. As the Lab Data Integrity Officer you will be responsible for coordinating and facilitating meetings with cross-functional groups within Quality Operations to discuss data integrity.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Lab Data Integrity Manger will act as the point person for Data Integrity for the organisation leading a multi disciplinary team and the key duties and responsibilities are as follows:
1. The Data Integrity officer will ensure operations run to regulatory policies with good documentation in place.
2. The role will assess all new equipment and instrumentation and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
3. Oversee Governance Team deliverables are on target, properly resourced and executed as committed. Must Communicate actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.Perform risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
4. The Data Integrity officer will play a key role in audits and demonstrate the requirements are in place to maintain operation.
To be successful in your application to this exciting opportunity as the Lab Data Integrity Manger we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science / Engineering or similar related field
2. Proven industry experience in Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP). Experience in HPLC and GC data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
3. A working knowledge and practical experience with Must have at least 7 years experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise. Project Management, Supervision or Management experience are preferred.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.