Job Title: Senior QC Manager
Role Type: Permanent, Full Time
Location: Dublin.

Our client is a leading pharmaceutical company based in Dublin, and they are looking to hire a Senior QC Manager on a Permanent, Full Time basis. This role reports directly to the site Quality Lead and oversees QC operations, working closely with a team of Specialists, Senior Analysts and Supervisors. This is a fully onsite role, and they are looking for an experienced QC Manager who can hit the ground running.

Duties & Responsibilities:

• Day-to-day 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. 

Skills & Experience Required:

• 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.

• 5-7 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.

• A minimum of 5 years of people management experience.

• 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.

Benefits

• 12.50% annual target bonus

• Yearly salary review

• VHI Health Insurance

• Private pension from day one

• Life insurance

• 24 days of paid annual leave, increasing

• Paid sick leave