JO-2409-541062
QC Manager required for pharmaceutical manufacturing facility in Blanchardstown. Reporting to the Site Quality Lead, QC Manager will be responsible for day to day management of Specialists, Senior Analysts and Supervisors on-site. Perm role, excellent benefits.
For a confidential conversation - do get in touch : Deirdre Murphy on 01 614 6178
• Responsible for management of both chemistry and microbiology labs, which includes the release of raw materials, packaging components and finished products to meet the production and shipping schedules as appropriate.
• Ongoing maintenance of the site stability programme.
• Ongoing maintenance of the retain samples programme.
• Liaise with manufacturing to ensure that raw materials, in-process lots and finished products are released in a timely and cost effective manner.
• Ensure that all laboratory personnel are trained in their appropriate duties in GMP and GLP through a defined structure programme and that training records are updated on an ongoing basis.
• Responsible to recruit and develop training plans as well as personnel development plans for all laboratory personnel.
• Assist in the preparation for internal and external audits by regulatory bodies.
• Carry out performance appraisals for QC laboratory personnel.
• Ensure analysis and approval of all validation data in a timely manner and approval of validation documentation as required.
• Ensure validation of test methods and method transfers are executed and documented as required.
• Responsible for the safety of all laboratory personnel and notification of any safety concerns to Quality Director/EHS Advisor.
• Responsible for the coordination and performance of the continuous improvement programme within the quality control laboratories.
• Financial management of resources and expenses of the Quality control function within budget agreed.
Requirements
• Bachelor's degree in a relevant field, such as pharmacy, chemistry, biology or a related discipline.
• Advanced degrees (Master's or Ph.D.) may be an advantage.
• Min 5 years of leadership experience in quality control laboratory (chemistry/microbiological) activities or a related area within the pharmaceutical industry with a focus on compliance with GMP and GLP.
• In-depth knowledge of relevant applicable regulations and guidelines such as EMA, ICH, EP and other global regulatory requirements.
• Experience in interacting and facilitating HA inspections and audits
• Strong technical writing skills.
