Validation Manager

HERO

Job Detail

Location Sligo
Salary Negotiable
Posted
Role Type Permanent
Contact Anna McGowan
email anna@hero.ie

Validation Manager

Apply Now

Job ID: JOB-12196
Validation Manager / Lead

We are currently seeking a Validation Lead for our client a Pharmaceutical company in Sligo. This role will reporting directly to the Quality Director, you will lead a high performing team that is responsible for the development and maintenance of the biologics validation program and ensure all regulatory, quality, and compliance requirements are met.

Responsibilities:

  • Develop, coach and mentor your team to perform to their highest capabilities
  • Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance/execution of Project Validation Plans and schedules
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents
  • Management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements.
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Requirements:

  • A relevant degree in engineering or scientific discipline with 3 years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
  • Demonstrated leadership capabilities to build and coach a diverse team

For further information on this role in please contact Anna McGowan on 0864667369 or email anna@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note:

Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Anna McGowan

JOB-12196

Apply Now

Validation Manager

Anna McGowan

Role Type Permanent
Contact Anna McGowan
email anna@hero.ie
mobile +353 86 466 73 69
linkedIn profile click here

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