Project Cqv Lead

3 weeks ago

Cork, Cork, Ireland PM Group Full time
Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs.
Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands.
We are seeking a highly experienced Project CQV Lead to join our client-side project management team.
They will be responsible for leading and coordinating all project commissioning and qualification activities and CQV personnel in line with the site project strategy.
The successful candidate will take ownership of project delivery from concept through to commissioning, ensuring scope, cost, quality, and schedule objectives are met.
You will provide technical leadership, strategic oversight, and coordination across both greenfield and brownfield pharmaceutical projects.
Responsibilities L ead and coordinate the CQV execution team (+ 10 CQV Engineers), ensuring timely execution and compliance with SOPs and current industry regulations Support and coordinate the transition to a digitized C&Q platform (Kneat Solutions) Ensure effective resource planning is established and managed throughout the project in line with schedule and associated CQV budget including the management of CQV personnel M anage and coordinate equipment qualification activities, including but not limited to FAT, SAT, Design Qualification, IQ, OQ and PQ Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives M anage and coordinate all CQV documentation including URS, IQOQ Protocols to support CQV activities Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards Support continuous improvement initiatives by implementing best practices in project execution and quality assurance Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols P rovide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
Qualifications Relevant qualification (Degree) and / or relevant experience of 10 + years in biotech / pharmaceutical industry qualifying GXP systems M inimum 5 years experience in a lead CQV role with responsibility for managing a commissioning and qualification team Experience of managing t eams or p rojects in a fast p aced and complex environment Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q p latform i.e.
Kneat Solutions Clear understanding and previous experience in deployment and execution of a RBV (Risk Based V alidation) process in line with the ISPE guidelines Experience with CQV Document Preparation for process systems/equipment including URS, TS, FS and the drafting of SAT/COMM, risk assessments, DQ, IQ, OQ protocols Clear und erstanding of regulatory requirements for EU and oth er regulatory bodies ensuring CQV is d elivered meeting all regulatory requirements and guidelines Excellent verbal and written communication skills, Experience in d eveloping a strong w o rking relationship with other departments Strong analytical p roblem-solving skills.
Dynamic decision maker, effective pl anner, and communicator M anage all coordinate all stakeholder engagement / senior management reporting Full understanding of current Regulatory Guidance, industry best practices, such as ASTM E2500 #LI-AM2

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