Validation Manager - Medical Devices
The Validation Manager is responsible for establishing, managing and implementation of the validation programme for processes, systems and products in compliance with regulatory requirements. The role shall develop and perform validation training, policies and procedures to ensure best practices are consistently performed. The position shall also support the business’s objectives, corporate policies, and world class manufacturing.
Main areas of responsibility:
- Develop & maintain validation policies, standards and procedures defining a risk-based approach to validation and operational compliance
- Generate and report metrics to monitor the performance of the validation system
- Maintain & disseminate current knowledge of regulatory requirements and industry best practice pertaining to validation
- Develop validation knowledge & skills throughout to ensure all personnel are able to fulfil their defined roles & responsibilities effectively
- Lead validation planning with cross functional teams to ensure that an appropriate risk-based approach is taken and then executed in accordance with procedures to meet project deadlines
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
- Manages all validation activities, which include the development, writing, execution, review and approval of validation plans, validation protocols and reports (IA/FAT/SAT/IQ/OQ/PQ/VSRs) etc
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Complete assigned non-conformance and CAPA investigations and prepare investigation reports.
- Participate in the development of the new processes, process transfers and continuous improvement, and issue resolution.
Qualification / Experience required:
- Science degree or other relevant degree or qualification preferably Lean Sigma trained & certified with good practical experience of its use both in QA & Manufacturing environments.
- The Validation Manager will bring specific experience and knowledge of FDA, GMP and Medical Device regulations relating to validation program requirements and validation documentation practices, with specific area knowledge in:
o Process validation / test method validation (this role also requires process development capabilities)
o Equipment Qualification / Computer Systems Validation
o Cleaning Validation / Sterilisation Validation
- Experience of working for a medical device organisation
- Validation, quality and change control management preferably within a medical device and a GMP regulated industry
- Team working with cross functional teams to ensure all regulatory, risk management activities (ISO 14971) & project requirements are met
- Ability to project manage using industry recognised tools
- Proven ability to comprehend and apply the principles of Statistical Process Control (SPC), sampling plans, factor analysis and correlation techniques
- Knowledge of FDA regulations 21 CFR Part 820 & Part 11 & validation requirements, European Medical Device Directives and International standards, such as ISO 13845 (Medical Device Standard)
- Working knowledge of industry practice, such as ISPE GAMP, ISPE Baseline Guides (i.e. Commissioning & Qualification)
- Experience of successfully presenting to FDA inspectors, Notified Body Auditors and other regulators
If you are interested in this role, please click apply now!
Harris Lord is acting as an employment agency for this role.
Keywords: medical device, validation, clean room, GAMP, IQ, OQ, PQ, Annex, GMP, FDA, DQ, ISO13485, IOS14971, 13485, 14971, medical devices, engineering, MDD, MDR,
- Medical Devices