Quality Control Manager required for a leading pharmaceutical organisation in the South East. The Quality Control Manager will manage and lead the site Quality Control activities and ensure all such relevant activities comply with GMP and Regulatory requirements.
Overview of Main Responsibilities (full job description available on request):
Execution of Analytical testing of all components, raw materials, excipient, intermediates, APIs, Final Product, and ongoing stability samples.
Release for use of all components, raw materials, excipient, intermediates, and APIs for further processing.
Qualification, calibration, and all maintenance of laboratory instruments.
Proactively aim to recruit high-calibre candidates to support the site's term Quality strategy.
Lead the QC function in preparation for, and during external agency audits and internal company audits.
Taking personal responsibility for supporting and developing others by acting as a coach or mentor.
Builds a performance culture by using systems of continuous performance measurement to improve on key performance indicators.
Develops close working relationships with customers and other key stakeholders.
Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines, and relevant legal requirements.
Participate fully in the site’s quality initiatives and ensure that all relevant quality standards are adhered to.
Management Policies relevant to your job role.
Ability to effectively lead, develop and motivate Quality team.
What the ideal candidate looks like:
Third-level science-based degree (preferably post-graduate).
Experience with Inspections by FDA, HPRA, and notified Body Audits
Knowledge of FDA 210/211 and FDA 820 regulations
Certified Qualified Person.
Member of an appropriate professional body (e.g. C.Chem MRSC).
Experience 3-5 years experience in a pharmaceutical/healthcare industry in a quality management capacity
Previous experience managing and developing large teams.
What you will get in return:
Competitive salary (depending on experience).
Share option scheme.
For a confidential discussion and more information on the role, please contact Aisling Lane.