Sunday, 26 May 2024 05:00

Validation Manager

   Ireland |  Full-time regular

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Posting Date :  2024-05-09

Job Identification :  165

Department  :  Validation

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The primary purpose of this role will be to lead and manage the Validation team on a day-to day basis ensuring that BAHL remains compliant in relation to Validation cGMP requirements and that Validation projects are adhering to established timelines.  In addition, the successful candidate will support all BAHL departments in relation to ongoing Validation activities.


Key Role Specific Requirements:


  • Leading the Validation Team to ensure that Validation project schedules and associated action timelines are adhered too through timely execution of the Validation Master Plan.
  • Scheduling all validation activities associated with the execution of the Validation Master Plan (VMP) while ensuring all validation project and production timelines are met. 
  • Build effective working relationships with all BAHL departments ensuring that there is minimal impact to production schedules and supporting department processes.
  • Leading the Daily Tier 1 team meetings to identify issues impacting on Validation project timelines and to develop remediation plans address these issues.
  • Represent the Validation department during Health Authority or Customer audits in relation to Validation matters.
  • Executing and maintaining the BAHL Cleaning Validation programme as per the VMP.
  • Preparing and executing Validation Protocols and completing associated Validation reports for Validation projects.
  • Preparing and executing validation test method validation protocols.
  • Ensuring investigation, review and reporting of OOS validation results is carried out and documented as per validation protocol.
  • Supporting Deviation, CAPA, FMEA, RCA and Change Control closure from a Validation perspective.
  • Report Validation KPI at scheduled Management Review meetings.
  • Coordinating of thermal mapping of BAHL equipment and warehouses in accordance with Validation Protocols, VMP and regulatory guidelines.
  • Conducting qualification of production and laboratory equipment in accordance with Validation Protocols, VMP and regulatory guidelines.
  • Supporting and coordinating the execution of the annual plant shutdown by liaising with Contractors and Maintenance.
  • Act as mentor to junior members of the Validation Team and ensuring relevant training (i.e., protocols, SOP’s etc.) is complete and up to date.
  • Maintaining the Validation Department training matrix and ensuring it accurately reflects training status of the Validation Team.
  • Keep abreast of all legislation and trends in order to provide appropriate guidance/direction to internal and external stakeholders on all areas of validation compliance.
  • Play an active role in the facilitation of company driven initiatives including continuous improvement (CI) programs across the board.


Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.


Competencies Required for the Role:


  • ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations.  Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
  • CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.
  • EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – to help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience.  Exhibit willingness to listen and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing.
  • PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
  • THOROUGHNESS/DETAIL ORIENTED – is ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.


Other Requirements:


Experience:

  • Strong experience working in pharmaceutical industry in a Validation role (4-5 years).
  • Strong experience in implementing a Cleaning Validation programme.
  • Experienced in New Product Introduction (NPI) and the role the Validation Department has in supporting these projects.
  • Experienced in equipment and process validation, with an in-depth knowledge of quality assurance, quality control and compliance aspects that are required to support these. 
  • Experienced in Continuous Process Verification (CPV)

 

Educational:

  • Bachelor’s degree in chemistry, biology, microbiology, or a related discipline.  

 

Technical:

  • Thorough understanding of quality systems and compliance to Eudralex and FDA cGMP requirements.

 

Behavioural:

  • Ability to interact readily and easily with key contacts (e.g., different functional groups).
  • A self-starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change.
  • Highly organised, with exceptional time management and prioritisation.
  • Critical thinking and evaluation of process problems.
  • Excellent interpersonal and communication skills.
  • Analytical knowledge, understanding and approach to tasks & problem solving.


Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.


Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.


Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.


Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.


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More Info at www.bimedacareers.com

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