Salary : Up to €53 per hour
REF Number : 00041766
Consultant : Jennifer Woolley
Sector : Pharmaceutical
Discipline : Qa / Validation
CK Group are recruiting for a Quality Assurance Specialist to join a global bio-tech company on a contract basis for 12 months in Dun Laoghaire, near Dublin.
The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
QA specialists will be required to understand and grasp a broad range of quality related competencies. In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner / point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
Key responsibilities include :
Perform all activities in compliance with company safety standards and SOPs
Provide 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.
Write, review and approve Standard Operating Procedures in accordance with company Policies.
Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide 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
Participates in customer complaint investigations.
Additional responsibilities may include :
Provide 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.
Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities
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.
Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
Co-ordinates and approves 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 line with business requirements
To be considered for the role, you should have the following skills, knowledge and experience :
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.