|Location: Haverhill, Suffolk||Salary: Negotiable|
|Sector: Engineering||Type: Permanent|
|Contact: Matt Henocq||Job Published: 24 days ago|
Senior Computerised Systems Validation Engineer
My client has invested significantly in Computerised Systems and they are recruiting for a Senior Validation Officer who will be a key player in this QA-CSV set up, interfacing with a wide variety of key stakeholders inside and outside the organisation.
In this position you will ensure a local and global framework for Computerized Systems Validation (CSV) for Automation, It, Laboratory and Process control systems in handling quality data (GxP data) in compliance with regulatory requirements for Pharmaceuticals, electronic records and electronic signatures.
This is a real opportunity for an individual looking for a varied role where you have the possibility to contribute to developing the quality and regulatory compliant organisation.
- To undertake validation duties assigned by the Validation Manager or QA CSV Team Leader.
- Provide support and guidance to site projects, operations to meet the quality and compliance requirements of the site and the wider company with respect to CSV.
- To prepare, execute and report validation documentation with respect to CSV.
- Review and approve validation deliverables and provide guidance in their creation.
- Drives continuous improvement.
- Supports maintenance of local computer system inventory.
- Keeps up to date on regulations and legislation with respect to CSV.
- Provides support during internal and third-party audits.
- Ensure all corrective and preventative actions in their value stream are completed within the agreed timelines.
- Complete Data Integrity reviews and subsequent remediation activities of site control systems and processes.
- Generate data maps to describe the data flows throughout the systems and to identify critical data control points/transactions.
- Identify data integrity gaps and propose solutions.
- Lead and/or assist with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps.
- Maintain core training and prior to conducting any activity ensure you are trained in the current version
- Specialist knowledge of CSV derived through both practical experience and theoretical studies, within the pharmaceutical / biotechnology industry.
- Excellent understanding of the regulatory expectations relating to CSV.
- A broad understanding of validation principles in general and the GMP expectations as applicable.
- In depth knowledge of GAMP 5.
- An understanding of Data Integrity in line with recent regulatory expectation.
- Experience of CSV in a pharmaceutical manufacturing environment.
- Working experience with Equipment Control Systems, IT systems and Lab systems / Automation systems.
- BSc in Scientific, Engineering, IT discipline or similar / equivalent experience.
- Good communicator. Attention to detail.
- Good organisational skills with ability to prioritise workload.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.