Job Overview:
We are seeking a Quality Assurance Senior Specialist to oversee all validation activities, ensuring compliance with current regulatory requirements, cGMP, and company SOPs.
Responsibilities:
* Oversight of all validation activities to ensure compliance with regulatory requirements.
* Validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes.
* Provision of QA oversight to the Commissioning, Qualification, and Validation (CQV) activities associated with facility start-up projects and supporting transitions from project phase through to sustaining phase with respect to validation activities.
Duties:
* Ensure quality oversight of qualification/validation activities for all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes.
* Review and approve validation documentation and associated data, including plans, URSs, quality risk assessments, protocols, and reports, to ensure conformance to SOPs, specifications, and acceptance criteria.
* Provide QA oversight and review of events/deviations, investigations, and change evaluations during qualification/validation activities, adhering to SOPs and cGMP requirements.
* Review SOPs related to qualification/validation activities.
* Support in Regulatory inspections and Client audits.
* Provide QA validations expertise to maintain validation status of the facility.
* Maintain an understanding of cGMP regulations and guidance regarding aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes.
* Coordinate QA validations activities to ensure schedule adherence and timely delivery of project deliverables.
* Manage and develop the QA validations team, including performance management, recruitment, and training.
* Perform other quality-related tasks as assigned.
Skills and Qualifications:
* Strong knowledge of cGMP regulations and guidelines.
* Ability to lead and manage a QA validations team.
* Excellent communication and project management skills.
* Proficiency in creating and maintaining validation documentation.
* Strong analytical and problem-solving skills.