Validation Manager

Loughrea, Co. Galway

BASIC SUMMARY:

An important role in the QA department, reporting directly to the Associate Director of Quality, the Validation Manager will be responsible for oversight and management of the site Process and Cleaning validation function and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments within the Chanelle Group.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
  • Contribute to the management of the validation requirements of Chanelle and third party suppliers and CMO’s
  • Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
  • To maintain and take responsibility for the cleaning validation strategy at Chanelle
  • Contribute to the management and responsibility of the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
  • Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications
  • Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
  • Establishing, implementing and directing validation and revalidation activities
  • Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate
  • Identifying training requirements in support of validation Department
  • Ensuring completion of validation protocols
  • Carry out Internal Audits as required
  • Responsible for the execution of Risk Assessments or Investigation reports relative to the role
  • Maintaining validation documentation system
  • Publish Monthly Validation Metrics on KPI
  • Required to Lead cross functional teams providing knowledge in resolution in any technical issues
  • Assisting in the preparation and hosting of associated regulatory and customer audits

COMPETENCIES:

  • Good verbal and written communication skills and the ability to work independently in analytical; environment
  • Good computer skills with Word, Excel and any other statistical programs
  • Knowledge of Process and Cleaning Validation
  • Ability to conduct internal audits
  • Ability to perform in external audits

QUALIFICATIONS:

  • Minimum Bachelor of Science or Engineering

PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)

  • To take reasonable care for their own safety, health and welfare at work and that if aby other person that may be affected by their actions or omissions while at work.
  • To cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.
  • Adheres to safety regulations by ensuring correct usage of PPE in laboratory and production areas.
  • Reports to the supervisor or health and safety representative without unreasonable delay of any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company.
  • Keeps work area safe, clean and tidy.
  • Required Training.
  • Manual Handling Training.
  • Working on PC

PERSON SPECIFICATION:

▪ B.Sc. / M.Sc. in Scientific Discipline

▪ Minimum 2 years relative experience in a similar position

▪ Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management

▪ Proactive, motivated, analytical and strategic thinker.

 

WORK ENVIRONMENT: (eg. Office, Production)

  • Office

Validation Manager

Reference No: J0753
Loughrea, Co. Galway