Senior QC Manager

My client, a global pharmaceutical company based in West Dublin is actively looking for a Senior QC Manager to join their team.

This is a full time, permanent position which will manage a team and is responsible for managing of the following functions - Incoming QC, QC Chemistry and QC Microbiology

They will also ensure the provision of an efficient, independent QC testing to verify that the final product is manufactured consistently, meeting pre-defined specifications and requirements. To provide analytical support to Manufacturing on quality related issues. Ensure that the requirements of cGMP are met at all times. To develop the skills, capabilities and contribution of direct reports and the QC department.

Key Responsibilities

• Management of QC department team to carry out required Incoming QC, chemistry and microbiology testing as required
• Ensure QC testing of clean utility, raw material, in -process, final container and post packaging ID is performed as per the production plan
• Oversee all QC systems and QC laboratory equipment, to ensure adherence to regulatory requirements and regulations
• Manage integrity of Laboratory data
• Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
• Ensure all equipment is validated, maintained, calibrated and requalified in line with site procedures and regulatory/compendial requirements
• Creation, review and update of test methods and SOPs to ensure all aspects of compliance are adhered to Drive and oversee process/product/OOS/deviation investigations
• Implementation of Corrective and Preventative actions
• Maintain, monitor and report QC department metrics and KPIs
• Ensure training and development of QC department team members in conjunction with team development and goals via the performance management process.
• Build succession plans.
• Development of QC department in line with business goals.

Required Qualifications, Experience & Skills

• BSC/ MSC or equivalent in chemistry, biochemistry, pharmaceutical science or related field

• Minimum 4 years supervisory/leadership/ management experience in QC with ability to motivate, guide, train, coach and develop subordinates. 

• 10 years progressive experience as an individual contribution in a fast moving GMP laboratory Environment
• Understanding and ability to apply 21CFR, USP, EP and ICH regulatory guidelines and directives Ability to institute a wide array of Standard Operating Procedures and GMP-based projects
• Strong knowledge of small molecule analytical technologies (e.g. GC, HPLC, AA, etc.). 
• Strong knowledge of aseptic filling microbial controls and required testing Method Transfer and qualification experience
• Equipment qualification experience
• Excellent communication skills at organisation, team and individual levels

If you are interested in applying for this role or discuss the position in more detail, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com