QA CQV Specialist

About PSC Biotech

Who are we

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.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

The Quality team have a great opportunity for a Quality Assurance Senior Specialist at our Dundalk facility.

QA CSQ/CQV specialist contractor/Consultant he will be reporting 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 controlled temperature units (CTUs) and shipping. An important aspect of this role is provision of QA oversight to the Commissioning Qualification and Validation (CQV) activities associated with the Dundalk Facility start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities

JOB RESPONSIBILITY

Ensure the quality oversight of the qualification/validation activities of all facilities utilities equipment computerized systems cleaning processes manufacturing processes storage areas controlled temperature units (CTUs) and shipping processes.

Ensure that all validation documentation and associated data including but not limited to; plans URSs quality risk assessments protocols and reports are reviewed and approved by QA for conformance to SOPs specifications and other applicable acceptance criteria.

Ensure that all events/deviations investigations and change evaluations that occur during qualification/validation activities have appropriate QA oversight QA review and approval and adhere to SOPs and cGMP requirements.

Review SOPs relating to qualification/validation activities.

Provision of support in Regulatory inspections and Client audits.

Provision of QA Validations expertise to maintain validation status of the facility.

Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities utilities equipment computerized systems cleaning processes manufacturing processes storage areas controlled temperature units (CTUs) and shipping processes.

Coordinate all QA Validations activities to ensure schedule adherence and on time delivery of project deliverables.

Manage and develop the QA Validations team including but not limited to activities such as performance management recruitment and training.

Other quality activities as needed and assigned.

Requirements

Bring energy knowledge innovation to carry out the following:

Education background/ Experience

or 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 a FDA/ EU regulated environment.

Thorough understanding of the validation requirements associated with a cGMP manufacturing facility

Strong technical aptitude is required.

Special knowledge

Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP FDA ISO) and the industry standards applicable to validation including but not limited to; GAMP ISPE ISO ASME and BPE.

Knowledge of trouble shooting and problem-solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams FMEA etc.

Skills

Independent and self-motivated.

Able to multi-task in fast-paced dynamic working environment.

Strong planning organisational and time management skills.

Critical thinking skills.

Able to operate across functional boundaries both internal and external.

Other requirements (e.g.: working time)

On-site