QA CQV Specialist

Overview Join to apply for the QA CQV Specialist role at PSC Biotech Corporation .
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of professionals in the Pharma/Biotech Industry. We offer a permanent contract of employment with exposure to working at top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition: Employees are the “heartbeat” of PSC Biotech. We provide empowering career development through Learning & Development, in-house training, mentorship, and guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations in quality, stay under budget, and meet timelines.
Role overview The Quality team has a great opportunity for a Quality Assurance Senior Specialist. The QA CSQ/CQV Specialist Consultant will report to the QA CSQ/CQV Lead. This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs and shipping. An important aspect is QA oversight of Commissioning, Qualification and Validation (CQV) activities for the start-up project and supporting the transition from project phase to sustaining phase with respect to validation activities.
Education background / Experience B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/medical device manufacturing in an FDA/EU regulated environment.
Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
Strong technical aptitude.
Special knowledge.
Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and industry standards for validation (GAMP, ISPE, ISO, ASME, BPE).
Knowledge of troubleshooting and problem-solving; experience with formal root cause analysis methods/tools (e.g., Ishikawa diagrams, FMEA).
Skills Independent and self-motivated.
Able to multi-task in a fast-paced, dynamic environment.
Strong planning, organizational, and time management skills.
Critical thinking skills.
Able to operate across functional boundaries, both internal and external.
Responsibilities Ensure quality oversight of qualification/validation activities for facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs and shipping.
Review QA for conformance to SOPs, specifications and acceptance criteria of all validation documentation and data (plans, URSs, quality risk assessments, protocols, reports).
Ensure events/deviations, investigations, and change evaluations during qualification/validation activities have QA oversight and approvals per SOPs and cGMP requirements.
Review SOPs related to qualification/validation activities.
Provide 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 related to validation/qualification activities.
Coordinate all QA validations activities to ensure schedule adherence and on-time delivery of project deliverables.
Manage and develop the QA Validations team, including performance management, recruitment, and training.
Other quality activities as needed and assigned.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
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