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 PropositionEmployees 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 client'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.
The Quality team havea great opportunity for a Quality Assurance Specialist at our Dundalk facility. QACSQ/CQV specialist contractor/Consultant, he will be reporting to the QACSQ/CQV Lead. This role is responsible for oversight of all validationactivities ensuring compliance with current regulatory requirements, cGMP andcompany 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 thisrole is provision of QA oversight to the Commissioning, Qualification andValidation (CQV) activities associated with the Dundalk Facility start -upproject and supporting the transition from project phase through to sustainingphase with respect to validation activities JOB RESPONSIBILITY· Ensure the quality oversight of thequalification/validation activities of all facilities, utilities, equipment,computerized systems, cleaning processes, manufacturing processes, storageareas, controlled temperature units (CTUs) and shipping processes.· Ensure that all validation documentation andassociated data, including but not limited to; plans, URSs, quality riskassessments, protocols, and reports, are reviewed and approved by QA forconformance to SOPs, specifications and other applicable acceptance criteria.· Ensure that all events/deviations,investigations, and change evaluations that occur duringqualification/validation activities have appropriate QA oversight, QA reviewand approval and adhere to SOPs and cGMP requirements.· Review SOPs relating to qualification/validationactivities.· Provision of support in Regulatory inspectionsand Client audits.· Provision of QA Validations expertise tomaintain validation status of the facility.· Maintain an understanding of cGMP regulationsand guidance in relation to all aspects of validation and/or qualification offacilities, utilities, equipment, computerized systems, cleaning processes,manufacturing processes, storage areas, controlled temperature units (CTUs) andshipping processes.· Coordinate all QA Validations activities toensure schedule adherence and on time delivery of project deliverables.· Manage and develop the QA Validations teamincluding, but not limited to, activities such as performance management,recruitment, and training.· Other quality activities as needed and assigned.
RequirementsBring energy, knowledge, innovation to carry out thefollowing:· Education background/ Experience· B.Sc or B.Eng in a Scientific or Engineeringrelated discipline (e.g. biochemistry, chemistry, engineering).· 3+ years'experience in a Quality Engineering/Quality Assurance/Quality Validations rolefor Biologics or related pharmaceutical/ medical device manufacturing in a FDA/EU regulated environment.· Thorough understanding of the validationrequirements associated with a cGMP manufacturing facility· Strong technical aptitude is required.Special knowledge· Deep knowledge of GxP regulations applicable tobiologics manufacturing (e.g. EU -GMP, FDA, ISO) and the industry standardsapplicable to validation, including but not limited to; GAMP, ISPE, ISO, ASMEand BPE.· Knowledge of trouble shooting andproblem -solving skills. Knowledge of formal root cause analysis methods andtools such as Ishikawa diagrams, FMEA etc. Skills• Independentand self -motivated.