Validation Manager

Recruiter
i Pharm Consulting
Location
East Sussex
Posted
08 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
i-Pharm has partnered with a global medical devices company to hire a Validation Manager on a permanent basis in West Sussex. The primary focus of this position is to be responsible for the management and implementation of the validation programmes processes, systems and products in compliance with the company’s regulatory requirements. ROLE RESPONSIBILITIES (not limited to)• Developing and maintaining validation policies, standards and procedures• Developing statistically based sampling plans for in-process and final testing and inspections, and validations• Preparing and controlling the validation budget• Oversee and manage validation and contractor resources• Complete assigned non-conformance and CAPA investigations and prepare the investigation reports• Validation, quality and change control management• Working cross-functionally to ensure that all regulatory and risk management activities are met (ISO14971)• Presenting to FDA inspectors, Notified Body Auditors and other regulatorsBENEFITS• Pension scheme• Childcare vouchers• Recognition awards• Company social events• A subsidized staff canteen• Free parking on site• Death in service cover• Generous holiday allowanceEXPERIENCE REQUIRED• Science degree or equivalent professional experience• Knowledge of FDA regulations, (21 CFR Part 820 & Part 11 validation requirements), European Medical Device Directives and International Standards such as ISO13485• Ideally Lean Sigma trained and certified with strong practical experience in QA and manufacturing environments• Experience in a medical device organisation• Strong technical report writing experience• Ability to travel as requiredABOUT i-PHARM CONSULTINGi-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.www.i-pharmconsulting.comTO APPLYIf you would like to discuss this vacancy further, please call Senior Delivery Consultant Rebecca Sparkes on +44 (0)20 3873 7067, or email rsparkes@i-pharmconsulting.com. If this role is not suitable, Rebecca is also available to discuss other possible positions or answer any general questions regarding your career and the current market.KEY WORDSWest Sussex / GMP / Medical Devices / Validation / Management / CAPA Investigations / ISO 14971 / SPC / FDA Regulations / 21 CFR Part 820 / ISO 13485

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