Senior QA CQV Specialist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dundalk
• State/Province Louth
• Country Ireland

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in morethan 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 modelby 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 adiverse-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 ourclient’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

The Quality team have a great opportunity for a Quality Assurance Senior Specialist at our 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 Facility start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities

Requirements:

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 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 biologicsmanufacturing (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 Ishikawadiagrams, 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 role

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 toSOPs, specifications and other applicable acceptance criteria.
• Ensure that all events/deviations, investigations, andchange evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review…