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Our client, a pharmaceutical company, is looking for an administrator to join them on a 3-month basis to provide QA support for the manufacture and distribution of products. The role will include ensuring that each product is manufactured and supplied to the marketplace in compliance with GMDP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.
Salary - £35k - £38k (£17ph - £19ph)
Location: Selkirkshire, Scotland
Hybrid working available
Key Responsibilities:
- Support appropriate project management meetings to keep abreast of ongoing activities relating to product quality and GMDP compliance.
- Support QAPs and QAM activities in relation to routine administration of GrtMeds QMS systems and processes
- Ensure that QAPS batch record reviews are carried out on documentation released from CMO facilities which require import under the RPi process, as necessary, prior to the release of product for sale and distribution in the UK/ GB.
- Perform RPi release step for UK/ GB imported products.
- Support one or more of the Quality System(s) - Documentation Control, Change Control, Customer Complaints, Auditing, Training, Invoice Processing etc
- Support the provision of reports of key performance indicators to QA management
- Participate in the review and recall of defective products in order to minimise patient risk
- Provide administrative support to QA and Operational functions as required.
Key Skills:
- A Life Science degree or equivalent professional experience/training in a GxP environment.
- Working knowledge of international GxPs, especially in the interpretation of MHRA and EU requirements, for the manufacture, control and distribution of commercial product.
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines.
- Familiar with Quality Management Systems e.g. ICH Q10.
- Good interpersonal and communication skills
- Attention to details
- Good analytical and problem-solving skills
- Team working
- Working experience of Quality Systems
- Self-starter with a good eye for detail and ability to complete tasks/ objectives
Please note that we will only contact those candidates that we assess as suitable for the positions we have currently available based on their experience, training, and skills. If we do not have anything suitable, we will not keep your CV for more than 30 days.
As an equal opportunity employer, Bucks and Berks Recruitment is committed to the equal treatment of all current and prospective employees and does not condone discrimination on the basis of age, disability, sex, sexual orientation, pregnancy and maternity, race or ethnicity, religion or belief, gender identity, or marriage and civil partnership. We aspire to have a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply.
