Senior QA Specialist
The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function
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 , including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.
* Perform all activities in compliance with 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 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.
* Provides training and advice to staff in order for them to perform their desired functions.
QA Technical Support and Disposition Function (may perform some or all of these duties)
* 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 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.
* 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.
* University degree. Engineering or Science related discipline preferred.
* Relevant experience working in the pharmaceutical or biotechnology industry
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* 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.
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