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 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 have
a great opportunity for a Quality Assurance 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
· B.Sc or B.Eng in a Scientific or Engineering
related discipline (e.g. biochemistry, chemistry, engineering).
· 3+ years'
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.