Quality , Science, Pharmaceutical & Food
QA Specialist – Carlow
PE Global is currently recruiting for a QA Specialist on behalf of our client based in Carlow:
11 month initial contract
Our clients Carlow Site offers a new opportunity for a Quality Assurance Specialist to join the quality team.
The Quality Assurance Specialist role supports the introduction and execution of new products, materials and drug substance into the Carlow facility.
The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
- Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
- Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
- QA oversight on the receipt and release of Drug Substance to site.
(Functions include, but are not limited to, the following)
- Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy.
- Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
- Participate as functional expert in the cross functional team that manages introduction of products and materials at Carlow.
- Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
- Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
- Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
- Provide quality oversight and direction for Material introduction process and external party management.
- Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
- Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used at Carlow are correctly set up.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
Experience, Knowledge & Skills
- 3-5 years experience in a quality role, ideally in a pharmaceutical manufacturing environments.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP preferred
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
- Good Collaboration Skills
- Ability to work as part of a team to determine priorities
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
- Demonstrated ability to drive the completion of tasks
- Proven decision making capability with accountability and responsibility
- Demonstrated ability to solve problems
Qualifications & Education
- Bachelor Degree or higher preferred: ideally in a related Science discipline
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***