Job Reference: FRS45430
Job Duration:
Start date: 09/06/22
Description:
QUALITY PROJECTS SPECIALIST
I am currently working with a well-established, global Pharmaceuticals company in the Midlands who are looking for a Quality Projects Specialist to join their team .Scope
The Quality Projects Specialist will be responsible for leading and coordinating project activities across the qualityorganisation , this will involve supporting the implementation of effective planning, scheduling and resourcing requirements and will support the management team and will function as a quality lead .
Duties & Responsibilities
* Lead project initiatives to optimise systems, methods, or processes to identify ways to streamline processes and eliminate bottlenecks.
*Develop tools and practices to drive and measure continuous improvement in Quality function across Quality Assurance and Quality Control.
* Work with Quality teams to identify opportunities for efficiency and elimination of non-value activities.
* Support the team with completion of Quality documentation and records and encourage best practice with authoring and progression ofsame.
* Work with leads and management on scheduling, planning, and resourcing .
* Assist with implementation of tools forplanning, scheduling, and resourcing to ensure testing and release of batches to meet required timelines.
* Participate in andlead OpEX initiatives to ensure Quality processes, systems and techniques in place are mapped out (value stream mapping) to ensure lean measures are introduced where possible.
* Provide support with project planning and coordination of in-process and batch release testing to support on-going manufacture.
* Support and participate in facility modification and future expansion projects as a quality project lead.
* Participate in and support GMP regulatory audits
* Support in the oversight and maintenance of the Quality Management Systems identifying areas for improvement & optimisation to support operational and release functions.
* Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Developmentto ensure quality objectives are understood and achieved.
* Maintain a contemporary understanding of cGMP regulations and guidance
Requirements
* Min BSc. Level 8 in a relevant discipline (e.g., biochemistry, chemistry, process engineering) or equivalent
* At least 5-7 years relevant experience in a Pharma /BioPharma Manufacturing environment.(essential)
* Experience with the use of LEAN and six sigma principles.
* Skilled in process mapping.
* Biotech/Pharmaceutical QA experience with a good knowledge of cGMP.
* Experience of interaction with cross functional departments.
* Good knowledge of regulatory and cGMPguidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk* Excellent interpersonal and communication skills, meticulous eye for detail.
Skills: GMP, ISO 17025,Quality Systems, Quality Projects Lead, Quality Manager, QbD, Process Mapping, LEAN,Six Sigma
Keywords: Quality Systems Manager Job, Ireland, Quality Systems Supervisor, QA Manager, GMP, Audits, QA job Ireland, QA Job Waterford
Industry: Pharmaceuticals
Salary: €65000 - €70000 per annum + Pension, Health Ins, Bonus, ,Life Ass
Salary Benefits: Pension, Health Ins, Bonus, ,Life Ass
Vacancy Type: Permanent
Job Skills: GMP, ISO 17025,Quality Systems Manager, QA
Contact Name: Felicity Farrell
Website: -
Direct Application URL: -