QC Lab Manager

QC Lab Manager

AbbVie

Cork, Ireland

Job Description

We are now looking for a QC Lab Manager to join our team in Cork. This person will lead a team of experienced QC supervisors and professionals to ensure that the lab is operating effectively to meet the needs of the Cork operations. This leadership role will actively engage with the QC leadership team, while also challenging and motivating the extended QC team. The manager will also be responsible for promoting and ensuring safety and Quality within the laboratory.

• Lead, motivate and mentor your team to maximize their effectiveness by clearly communicating task details and goals to your team members, allowing them to work effectively
• Lead QC Supervisors and QC Planner to ensure batch release plans and schedule adhearance are achived.
• Establish, maintain and report key performance indicators for the department with respect to batch release.
• Lead the QC trainer to ensure training is both robust and proactive as well as ensuring it is suffiecent to meet the needs of the department
• Embed an environment for continuous improvement and simplification
• Ensure Lab is Audit Ready at all times and be responsible for presenting and taking ownership of own area during regulatory inspections and corporate audits.
• Actively participate in internal and external audits and follow up on audit findings
• Responsible for setting annual goals, completing reviews, growth plans and performance management of the team.
• Liaise with cross functional teams regarding sampling and testing and adhering to schedules and priorities.
• Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.
• Foster a positive progressive culture within the lab that focuses on EED&I principles and encourages development for all personnel on a continuous basis
• Assist in the resolution of specific manufacturing quality problems as required.
• Responsible for the timely execution and completion of all phases of chemical testing of raw materials, intermediates and finished products.
• Carry out specific tasks and projects as delegated by the Senior Quality Manager, Quality Director and Site Director.
• Ensure management is kept informed of system failures on a regular basis to ensure corrective/preventive action is taken where required.
• Manage Lab team towards achieving day to day and long term goals and provide the training/support necessary to ensure this.

Qualifications

• M.Sc./B.Sc. in Chemistry or related discipline Job/Technical Skills
• Minimum 3 years experience in the pharmaceutical industry in a laboratory role, in a supervisory capacity. Good knowledge of QA/QC operations with detailed knowledge of specifications, test methods, lab testing equipment.
• Experience working within a GMP regulated environment.
• Excellent conflict handling skills.
• Good interpersonal and communication skills essential for working across multi-functional teams.

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Ireland      On-site      Quality Assurance      AbbVie