Senior Quality Assurance Professional – QA Technical Support
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which 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 TS Specialist will be required to understand and grasp a broad range of quality related competencies.
- Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
- Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet regulatory expectations.
- The QA professional will review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/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.
- Review and approval of Master Batch Records and SAP BOMS
- Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
- Perform all activities in compliance with safety standards and SOPs
- The next QA professional will have BSc Engineering or Science related discipline preferred as well as 5 years relevant experience working in the pharmaceutical or biotechnology industry ideally
- Excellent written and verbal communication skills
- Strong organizational skills, including ability to follow assignments through to completion
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
- Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections.
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