£50,000 – £55,000 (possible flex for the right candidate)
Scantec are partnering with a successful scientific healthcare company who are going through rapid expansion are looking to add the new post of QA Manager to their site in North Wales.
The successful candidate will support the Operations Director and Chief Scientific Officer as they move forward with their new MHRA approved site as part of their future expansion plans.
The successful candidate will be able to influence the direction and growth of the business. In return they can offer a fantastic opportunity for you to develop within the business professionally and put a real stamp on the role.
The company is currently commercialising their ground-breaking diagnostic product which will be marketed as a Pharmaceutical product moving forward into the future.
Responsible for leading the Quality department. Working closely with all departments, the Quality Manager will provide GMP and regulatory expertise whilst ensuring the business is prepared for customer and regulatory audits and inspections.
Ensure compliance and implementation of the Pharmaceutical Management Systems;
Approving specifications, sampling instructions, test methods and other quality control procedures;
Ensuring all necessary testing is undertaken on ingredients, packaging materials, facility processes and finished products;
Evaluating batch records and approving/rejecting ingredients, packaging materials, and finished products;
Approving and monitoring contracted analysis;
Named QC on pharmaceutical manufacturing license (MIA) IMP;
Authorship and review of SOPs, Protocols and Risk Assessments, preparation and review of OOS investigations and deviation reports.
Ensuring that all test methods used in the QC Laboratory (when installed) have been validated appropriately and that test results are recorded and checked.
Involvement in audits both from internal and external parties
Keep up to date with current literature, test method developments and regulatory requirements.
Qualifications and Experience:
Science based degree in relevant field / advanced degree preferable.
Experience (five years plus) of management in a pharmaceutical quality environment.
Experience hosting MHRA audits, other regulatory audits and customer audits.
Extensive knowledge in a broad range of pharmaceutical activities and quality systems.
Knowledge of regulations and guidelines relating to GMP.
Excellent oral (including presentation) and written communication skills.
Excellent interpersonal skills and ability to develop and maintain relationships internally and externally to the business.
IT competent (including Microsoft office) and statistical analysis of analytical QC data.
Excellent organisational skills and the ability to work under their own initiative.
Dedication to the role and the business exhibited through attendance and a willingness and desire to learn and take part in areas and projects outside of the scope of the role.
Perform above activities in-house and with collaborating bodies as required liaising closely with the Operations Director and Chief Scientific Officer.
Comply with Health and Safety and GDP regulations.
Experience of working with biologicals.
Experience in GLP.
Working as a member of a small team, experience with start-ups
Scantec Personnel Limited is acting as an employment business and an employment agency. For contract or interim roles (and unless otherwise stated), all pay rates stated are on a Limited Company basis. Agency PAYE, Umbrella and CIS (if applicable) engagement models are also available, which will result in a different pay rate than advertised above.
Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website
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