J5323East Riding of YorkshirePharmaceutical Permanent£60,000 to £75,000 per annum - DOE Full Time16/03/2018Quality Assurance - Validation Quality Assurance – GMP Quality Assurance - GDP Quality Assurance – CSV Quality Assurance - GxP
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An exciting opportunity for a CSV Manager, to join a global manufacturing company based in the Hull area has become available. As the CSV Manager you will be responsible for ensuring that the business is compliant with all applicable regulatory and corporate requirements, through a combination of quality review across the organisations GxP global systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Manager will be varied however the key duties and responsibilities are as follows:
1. You will manage team resources to give adequate coverage to the different systems as activities and changes dictate.
2. You will ensure validation and change control is carried out correctly, particularly to satisfy regulatory & organisational requirements.
3. As the CSV Manager you will manage the review and delivery of key documentation that is required to support validation activities.
4. You will work with the business system owners & IS teams to support audits (internal & external) across the product lifecycle to confirm compliance of the system with local and regional standards.
To be successful in your application to this exciting opportunity as the CSV Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or IT related discipline or a significant amount of experience in a CSV related role.
2. Proven industry experience in system maintenance within a heavily regulated environment and compliance of GxP regulations.
3. A working knowledge and practical experience with GAMP systems, eQMS, systems validation, test script writing and system maintenance.
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.