Berkley Pharma & Life Science are currently seeking a QA Manager/QP for our client a Global pharmaceutical company based in Dublin.
Ref: 5040183
Role/Opportunity:
• To manage and lead the Pilot Plant site Quality Assurance Team, leading the construction and maintenance of the Quality Management System.
• This role will act as the primary site QP and assume full responsibility of the release function in line with EU directives for the certification of clinical materials.
• The individual will act as the subject matter expert with respect to the IMB and FDA along with providing QP support and guidance to business lines with a focus on drug product clinical supply manufacturing, assembly, testing, release operations, commissioning, qualification and process development.
• The position will have overall responsibility for internal and external audits, the vendor management programme and the oversight of the training system.
Skills/Experience:
• Educated to degree level and/or 10 years plus experience in pharmaceutical QA/QP roles.
• Demonstrated previous QP positions.
• Have had previous experience of external influence in the pharmaceutical industry including front line regulatory interaction.
• Capable of forming strong professional relationships across all functional lines and gain the respect of those in partner lines.
• Strong leader and able to work well under pressure.
• Professional in conduct.
• Willing to expand knowledge base and learn and then implement the new learning.
• Efficient and well organised in work execution practices.
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia
For more information go to http://www.berkley-group.com
To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sinéad Hawes on +353 (0)1 8724667 or send your CV to science@berkley-group.com
