West Pharma Validation Specialist 

Ireland, Dublin 

505746681

Summary:

• This role reports to the Senior Automation Engineer.
• The role-holder will act as the Commissioning, Qualification and Validation (CQV) Subject Matter Expert (SME) supporting Engineering and Operations projects.
• The role will support projects through the project lifecycle from determination of user requirements through to approval of PQ and subsequent revalidation(s).

Essential Duties and Responsibilities:

• Generation and approval of CQV procedures and documentation templates.
• Performance and documentation of a Validation Impact Assessment (VIA) for each project.
• Generation and approval of Commissioning, Qualification and Validation Master Plans (CMP, QMP, VMP) as appropriate for each project.
• Provision of CQV input into the definition, documentation, and approval of User (Customer) Requirements.
• Preparation, review, and approval of CQV documentation, such as user requirements and other specifications, risk assessments, requirements traceability matrices, protocols, and reports, through all phases of the project including DQ, FAT, SAT, IQ, OQ and PQ, working in conjunction with West/Customer program Quality representation.
• Management, control, and approval of the use of vendor documentation, such as Test Plans, to support system test phases in compliance with the West QMS.
• Leadership of and participation in test phases and activities including DQ, walk-downs, FAT, Commissioning/SAT, IQ, OQ and PQ.
• Generation, maintenance, and approval of a Requirements Traceability Matrix (RTM) for each validated system.
• Leadership of risk assessment processes, such as System/Component Level Impact Assessment (CLIA/SLIA) and Quality Risk Assessments (QRA).
• Participation in equipment process and/or Design (P)FMEAs.
• Review and approval of third party generated documentation, such as FDS, HDS, SDS and test plans, in conjunction with West/Customer program Quality representation.
• Generation and management of change requests and associated actions on MasterControl.
• Generation and management of non-conformances and associated actions on MasterControl.
• Generating and management of a CQV document tracker.
• Archiving and filing of CQV documentation associated with the project, including hard-copy and management of soft-copy archival on MasterControl.
• Leading the review and disposition of all attribute and variable data against customer specification / drawing e.g., Analysing and reporting of key measures eg. Ppk's, Cpk's, FOT/FAT visual inspections.
• Provision of CQV support and expertise to the resolution of customer issues.
• Prepare data/presentations and attend review meetings with the customer.
• Implement best practices principles into West QMS as applicable.
• Support internal and supplier audits.
• Trending and tracking of Validation data to drive improvements e.g., sampling data, number of non-conformances, project protocols and reports.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance with all local site Environmental, Health and Safety regulations
• Compliance with all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Basic Qualifications:

• Third level qualification, in Engineering/Quality/Science. Candidates with exceptional and relevant work experience may also be considered in lieu of degree qualifications.

Preferred Knowledge, Skills, and Abilities:

• Must have a third level degree qualification in an Engineering, Quality or Science discipline.
• Must have a minimum of 3 years’ post graduate experience in a CQV role in a GMP-regulated high-volume manufacturing environment (i.e., within the Medical Device/Pharmaceutical sector).
• Must have an in-depth knowledge of CQV practice in a GMP-regulated environment.
• Must have a good working knowledge and understanding of Computer Systems Validation (CSV) as an integral part of the CQV process.
• Must have a thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820.
• Must have a thorough understanding of statistics and Statistical Process Control (SPC) and ideally have a good working knowledge of Minitab.
• Must have excellent oral and written communication skills.
• Must be a self-starter, capable of acting on own initiative and working independently and being able to prioritize and organise tasks.
• A good working knowledge and understanding of plastic component manufacturing and assembly is desirable.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is desirable.

Travel Requirements:

No travel requirements with this role

Physical & Mental Requirements:

Physical

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.
• Job-related activities that require physical activity:
• Being able to stand or walk to use communal office equipment (Scanner/Printer etc...)

Mental

• Good team worker as well as ability to work independently.
• Applies appropriate judgment to resolve routine situations.
• Writes clear, concise, and neat information.
• Foresight and planning abilities to multitask and manage competing priorities.