Mantell Associates are exclusively partnered with an extremely exciting pharmaceutical manufacturing that specialise in the API, drug delivery system, inhalation, dosage forms, batch manufacturing, oncology, clinical trials space!
Due to continued success our client, they are now Senior Quality Assurance & Control Manager. This role will suit someone with substantial prior experience in QA within a clinical trials unit or related pharmaceutical industry environment and looking to step up into a leadership career.
Determine the quality by preparing and analysing samples.
Ensure all work is performed in accordance with the cGMP and FDA guidelines.
Maintain and calibrate the equipment as required to ensure all operations align with specified requirements.
Manage SOP’s and quality documents as well as internal CAPA’s and IR’s.
Conducting and facilitating internal and external audits and maintaining a rigorous audit schedule.
Recruits, leads and develops the QC team.
Preserves license to operate and ensures implementations of remarks from any audits.
Prepares and participates in audits with authorities and customers.
Develop a fit for purpose approach based on risk assessment for QMS appropriate to clinical phase project advancement (ph I, II, III) or to commercial.
BA or BS degree in related field.
Experience working in a cGMP environment and laboratory practice.
Strong technical and computer skills.
At least 3 years of experience in a cGMP biopharmaceutical environment, including a.
Team leader and excellent communicator, quality-minded and customer-oriented.
Experience in QC equipment qualification.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting organisation. For more information on this role, please contact Sofia Furlan on +44 (0)2038547728 or email@example.com.