JOB PROFILE: Validation Manager

INCUMBENT’S NAME
JOB TITLE / Validation Manager
BUSINESS UNIT / Quality and Regulatory Affairs
LOCATION / Worthing
REPORTS TO / Head of Quality
OBJECTIVES
PURPOSE OF JOB / Responsible for establishing, managing and implementation of the validation programme for Rayner 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 Rayner’s business objectives, corporate policies, and world class manufacturing.
KEY ACTIVITIES
RESPONSIBILITIES
Summarise key skills and experience required – link to essential/desirable/ personal skills required in brief/spec /
  • 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 Rayner to ensure all personnel are able to fulfil their defined roles & responsibilities effectively
  • Lead validation planningwith cross functional teams to ensure that an appropriate risk-based approach is taken and then executed in accordance with Rayner proceduresto 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.
  • Identify compliance risks associated with Rayner facilities & systems and actions to mitigate risks to required levels
  • Support regulatory inspections and audits in order to present Rayner’s compliance status
  • Development of Standard Operating Procedures, Quality Plans and Inspection Criteria
  • Prepares and controls the validation budget
  • Oversees and manages validation and contractor resources

KEY PERFORMANCE INDICATORS /
  • Delivery of projects in a timely manner & executed in accordance with policies, standards & procedures to realise benefit to Rayner
  • Successful completion of audits and inspections to maintain certification

KEY RELATIONSHIPS / Internal:
  • Operations & Production
  • Research & Development
  • Quality & Regulatory Affairs
  • Facilities
External:
  • Suppliers
  • Regulatory Bodies

CANDIDATE PROFILE:

QUALIFICATIONS/ TRAINING / 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.
EXPERIENCE
(E.g. health care industry, multinational company, what level/types of roles etc.) /
  • The Validation Engineer will bring specific experience and knowledge of FDA, GMPand Medical Device regulations relating to validation program requirements and validation documentation practices, with specific area knowledge in:
  • Process validation / test method validation (this role also requires process development capabilities)
  • Equipment Qualification / Computer Systems Validation
  • Cleaning Validation / Sterilisation Validation
  • Experience of working for a medical device organisation, in particular intraocular lenses would be an advantage.
  • 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 11validation 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

COMPETENCIES
(knowledge, skills and attributes – including language requirements, ability to travel, etc) /
  • Excellent interpersonal skills
  • Excellent communication skills both written and verbal
  • Self-Starter / Team Player / Minimal Supervision
  • High standard of technical report writing
  • The ability to read, analyse and interpret scientific and technical reports and respond to enquiries from regulatory agencies
  • Must be able to plan, organize, and implement multiple concurrent tasks.
  • Ability to travel, as required