Senior Quality Assurance Specialist x5 - Dublin
Alex Tosney at CK Science is recruiting for 5 Senior QA Specialists to join a pharmaceutical company based in Dublin. These positions are contracts with durations between 6 and 12 months.
The main purpose of the role will be to provide quality oversight of warehouse operations, including disposition of raw materials, project support and change control management.
Further responsibilities will include:
- Performing all activities in compliance with safety standards and SOPs
- Providing Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Writing, reviewing and approving Standard Operating Procedures in accordance with company Policies.
- Participating in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and providing active input into shaping the future direction of these systems.
- Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
- Participating in customer complaint investigations.
- Providing training and advice to staff in order for them to perform their desired functions.
- Providing overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations.
- Acting as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations.
- Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review.
- Reviewing and approving validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
- Co-ordinating and approving the preparation of reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.
- Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University degree. Engineering or Science related discipline preferred.
- Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
This is an excellent opportunity to join a leading pharmaceutical company on a contract basis.
For more information or to apply for this position, please contact Alex Tosney on 01246 457 700 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH34776 in all correspondence.