Are you a Validation Specialist with experience in the pharmaceutical sector? An opportunity has arisen for a CSV Specialist to join a well-established team on...
Are you a Validation Specialist with experience in the pharmaceutical sector? An opportunity has arisen for a CSV Specialist to join a well-established team on Merseyside.
About the organisation:
You will be working for an international manufacturing company, who offer services to the pharmaceutical sector.
You will be awarded with a salary of around £60K, 15% bonus, 25 days holiday (plus bank) and a 15% pension (5% personal, 10% company).
About the Job:
The role is a 12 month fixed term contract and the responsibilities are as follows.
- Manage the Periodic Review Process
- Perform external audits of vendors from a CSV perspective
- Establish the validation and compliance strategies and approaches within the site local projects
- Ensure adherence to Teva Standards and applicable regulatory requirements and practices,
- Validate manufacturing systems, Laboratory Systems and Business Systems
- Work under pressure and to strict deadlines
- Train people if required in CSV
- Provide weekly updates to the CSV Manager and escalate any issues as they occur
- Lead on projects as required
You need to have specialist knowledge of CSV derived through both practical experience and theoretical studies, within the pharmaceutical / biotechnology industry.
You will have an excellent understanding of the regulatory expectations relating to CSV and a broad understanding of validation principles in general.
- In depth knowledge of GAMP
- An understanding of Data Integrity in line with recent regulatory expectations
- Minimum of degree in a relevant discipline, or equivalent
- Experience of CSV in a pharmaceutical manufacturing environment
- Working experience with manufacturing systems (i.e. PLC/SCADA), Lab systems and business information systems
How to apply:
Apply now via the SRG website.
If this role is not quite right for you, but might be for somebody in your network - please forward this onto them. SRG pay a referral fee for any successful candidates.
Loz Mitchell - Pharma
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.