QA Validation Specialist (remote work available)

I8589

QA Validation Specialist - Kerry (remote work available) DPS currently have a requirement for QA Validation Specialist based from the Kerry area. The role will be responsible for the assessment and approval of internal request for Technical Change and maintenance of the change control procedure as well as the approval of validation documentation.

Category:
Control Quality
Location:
Munster
Years of Experience Req.:
3 years +
Date Posted:
12/05/2021
Days Remaining:
43
Employment Type:
Contract
Education Level Req.:
Third level Degree (Level 8)

QA Validation Specialist - Kerry

DPS currently have a requirement for QA Validation Specialist based from the Kerry area. The role will be responsible for the assessment and approval of internal request for Technical Change and maintenance of the change control procedure as well as the approval of validation documentation.

The successful QA Validation Specialist will have a minimum of 3 years’ experience in a cGMP regulated manufacturing environment.

Experience covers all aspects of working within highly regulated Pharmaceutical environments, including qualification on new and modified equipment, and initiating and completing project work within cross-functional teams.

 

Responsibilities will include:

  • Overall responsibility for the assessment and approval of internal Request for Technical Change and maintenance of the change control procedure.
  • Approval of validation documentation.
  • Good ability to interpret data. Guidance on the validation requirements is an essential part of the role.
  • Preparation of quarterly and annual change control review report. Ensuring that change controls are closed out in a timely manner.
  • Ensuring compliance with regulatory requirements and expectations. As the role involves approving validation documentation and RTCs for both nonsterile and sterile manufacture, the candidate should be familiar with the relevant regulatory requirements.
  • Approval of Validation life cycle documentation
  • QA representative for site projects
  • Investigating and generating deviations in conjunction with other departments
  • Ensuring delivery of a consistent approach to SIP Qualification
  • Generating periodic review reports for drug products and automated systems and ensuring adherence to periodic review schedule

 

Attention to detail and strong technical skills with ability to interpret data are essential to this role. The successful candidate must have a good understanding of both Analytical and Production processes.

Must have the ability to work on own initiative and as part of a team. Excellent interpersonal skills are required.

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