Quality Assurance Specialist

RT Lane Recruitment
R.T. Lane Recruitment are currently recruiting for a Quality Assurance Associate Specialist to work with a Pharmaceutical Company in Carlow.
This is an 11-month contract with strong potential for extension.
**Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland**
** Please note due to a high volume of applicants you will only be contacted if suitable for the position. **
Brief outline of Role:
Responsible for ensuring that the process for the manufacture of drug product onsite and is following cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with my client’s requirements to ensure compliance, safety and reliable supply to our customers.
Roles and Responsibilities:
- Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
- Review and approval of SOP’s, cleaning verification/validation data and other documents as necessary for the IPT department.
- Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
- Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
- Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
- Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained.
- Ensure all work is carried out in line with SOP’s, training or other quality systems such as change controls where applicable.
- 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 Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
- Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
Essential Criteria:
- Third Level Degree qualified in a Science/Technical or related discipline.
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
- GMP Audit experience in the pharmaceutical industry
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie
To apply for this job email your details to michelle@rtlanerecruitment.ie.