Job Reference: FRS51573
Job Duration:
Start date:
Description:
An exciting opportunity has come available for an experienced QA Validation Engineer to join a leading biopharmaceutical company.
Ideally you will have a minimum of 3 years' experience delivering robust and regulatory compliant validation plans and protocols.
Within this position you will be play a key role as part of a strong project team in delivering QA Technical support and oversight to Qualification and Validation activities of the Manufacturing facility and QC Laboratories.
The Position…
* Permanent position
* Highly attractive salaryand benefits package on offer
* Fantastic opportunity to join a growing and innovative organisation at an exciting stage of the business.
* Friendly, inclusive and collaborative working environment.
* Excellent opportunities for career progression and advancement.
* Days only role - with flexible working hours.
Responsibilities ( A snapshot…)
* Preparation and Maintenance of the site validation plan.
* Maintenance and archiving of Validation/Qualification documentation.
* Interface with other departments such as Engineering, QC Laboratories, Operations, Supply Chain and Process Development to ensure that validation project plans are understood and adhered to.
* Clearly communicate and/or provide training in the required validation standard to both staff and contractors.
* Review and approve validation, qualification protocols and reports.
* Provide oversight to project-related Deviations.
* Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
Requirements
* You will be Qualified to Degree Level in a related Engineering or Science discipline.
* Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
* Extensive experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
* Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.
* Experience in using risk assessment tools including FMEA.
* Ability to balance needs of the business with the needs of the Regulatory challenges.
* Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.
Next Steps:
APPLY!
Click Apply now to review the full details and job description for this amazing opportunity or contact Kerry on 0860443981 for an informal chat.
Industry: Pharmaceuticals
Salary: €60000 - €70000 per annum + Healthcare, pension, etc
Salary Benefits: Healthcare, pension, etc
Vacancy Type: Permanent
Job Skills: Qualification,Validation, GMP, EU/FDA GMP guidelines
Contact Name: Kerry Rickard
Website: -
Direct Application URL: -