My client, a global pharmaceutical company based in South West Dublin is actively looking for a Filling Manager to join their team.
Summary of position
The Filling Manager will lead the Filling Department in the qualification and validation of the New Albumin Filling Plant. This will include the completion of Medias, Conformance lots to meet NDA Submission filing timelines, as well as audit readiness and commercialization of the new facility.
The Filling Manager will also be responsible for directing the output of the Filling Team, ensuring best practices are applied to and adhered to in cleaning and maintaining the workplace, assembling, disassembling and operating production equipment (Final Filling Assemblies, Filling Machine, Over-wrappers, Pasteurisers, Autoclaves, In process equipment etc) as per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.
- Meet with cross-functional management staff to evaluate project/production/operation’s needs, resolve problems and obstacles, provide resources, reset direction and maximise effective interactions and discussions
- Assure the appropriate interaction with support groups such as Quality, Technology, Engineering & Maintenance, Supply Chain, Regulatory Affairs, EHS and Human Resources.
- Direct, oversee and participate in the recruitment, selection, promotion, and performance management of the Filling team.
- Lead and develop other Subject Matter Experts and continue to be a Technical Expert, leading a culture of innovation, efficiency and cost reduction in the Filling Department
- Direct and manage the oversight on new equipment purchasing and vendor relations, project budgeting, resource planning, etc for all equipment for Filling (Filter Integrity testing etc)
- Ensure that operations are managed in a cost-effective manner in line with budgetary objectives.
- Promote a culture of continuous improvement through the use of Operation Excellence tools and methodology. Through the use of Six Sigma/Lean Manufacturing Tools, improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste.
- Direct the efforts of staff in compliance with all regulatory requirements, cGMP and company policies, procedures and goals.
- Lead projects as required and all personnel associated with it (Data Historian, Electronic Batch Records) etc
Experience, Skills & Knowledge Required
· Knowledge of Filling and Aseptic Practices, sterilization, GMP regulations and Quality operations.
· 8+ years Operations management experience within a Pharmaceutical environment.
· BA/BSc in an Engineering or Scientific Discipline, or similar
- Demonstrated leadership skills with ability to motivate, guide, train, coach and develop teams.
- Strong organizational, analytical, problem-solving, skills. Ability to analyze detail and perform structured decision-making on a daily basis.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Ability to read and understand specification sheets, drawings, regulations (cGMP, QS, ISO).
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 [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com