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Validation Manager GMP

Cranleigh Scientific
Job LocationMaidstone
EducationNot Mentioned
Salary£45,000 - £55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Due to additional investment and the completion of new manufacturing facility, a global biotech company requires a Validation Manager to join its team. Your role will be to direct the development and implementation of validation test procedures to ensure product(s) meet appropriate regulatory agency validation requirements. You must have proven experience and knowledge of validation processes within a GMP environment.The Role:Directs the development and implementation of validation test procedures to ensure product(s) meet appropriate regulatory agency validation requirements, internal company standards and industry current practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements. Selects, develops and evaluates personnel to ensure the efficient operation of the function.Responsibilities:Will perform some or all of the following:

  • Manage the day to day activities of the Validation team and development and performance of direct reports on a day to day basis; interact with many different functions and levels within the organisation
  • Responsible for coordinating and supporting validation activities of new facility
  • Co-ordinate and perform validation projects activities for all facilities, equipment and processes operated in compliance with Current Good Manufacturing Practice(cGMP) requirements
  • Establish and maintain best practices for departmental procedures to ensure effectiveness to validation requirements
  • Provide direction and expertise in the management of validation activities
  • Prepare, execute and report validation protocols
  • Rationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met
  • Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to production
  • Maintain an awareness of regulatory developments in the validation field and brief Kent Operations personnel as appropriate
  • Attend meetings, both internal and external, representing the department in a professional manner
  • Ensure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOPs) etc.) for equipment and facilities
  • Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production
  • Attend meetings, both internal and external, representing the department in a professional manner
  • Participate in audits by customers and regulatory authorities
  • Support Environmental Management System (EMS) activities and compliance per ISO14001
  • Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects
    • positively on the company and is consistent with the companys policies and practices
  • Carry out duties in compliance with established business policies
  • Additional duties, as assigned
    • Experience Required:
  • Degree level, preferably in Chemistry, Biology, Engineering or a Related Subjects
    • Skills / Pre-requisites:
  • Knowledge of cGMP, including validation requirements for cGMP applications
  • Understanding of ISO 9001 and ISO13485 Quality Systems
  • Ability to author and execute validation reports
  • Ability to write validation related procedures, including Validation Master Plan (VMP)
  • Cleaning validation knowledge
  • General knowledge of sterilization validation, water system validation, HVAC system validation, temperature mapping, and data integrity
    • Required skills
  • GMP - IQ -OQ - PQ - HVAC- Equipment Validation - ISO 13485

    • Keyskills :
    GMP - IQ -OQ - PQ - HVAC- Equipment Validation - ISO 13485

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