About PSC Biotech Ltd Who we are? 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.Responsibilities:· Accountable to provide quality oversight to
validation and equipment qualification activities to ensure these activities
are compliant with all applicable regulations, company and contractual
obligations.· Accountable for review and approval of
commissioning and qualification activities, including the pre and
post-execution review & approval of all validation lifecycle documents.· Accountable for providing guidance on creation
of equipment lifecycle documentation, e.g. URS, FAT, SAT, IQ, OQ, PQ protocols
and reports, risk assessments, technical specifications, 21 CFR Part 11
assessment, Data Integrity Assessment, Configuration Specifications, Design
specifications.Participate or lead investigation, where possible related to
discrepancies identified during qualification activities· Review & approve SOPs, Deviations/Event,
CAPAs, Change Controls, Periodic Maintenance plans and user access request’s
etc..· Effective interfaces with internal and external
stakeholders to ensure effective communication· Align with company’s Quality Goal and Strategy
to set the Quality Goal, as well as monitor result and employee performance· Provide guidance to operation personnel
regarding commissioning, qualification and validation. Work with the team on
continuous improvement activities.· Comply with company requirements on EHS· Perform other tasks as assigned by QA department:· Accountable to provide quality oversight to
validation and equipment qualification activities to ensure these activities
are compliant with all applicable regulations, company and contractual
obligations.· Accountable for review and approval of
commissioning and qualification activities, including the pre and
post-execution review & approval of all validation lifecycle documents.· Accountable for providing guidance on creation
of equipment lifecycle documentation, e.g. URS, FAT, SAT, IQ, OQ, PQ protocols
and reports, risk assessments, technical specifications, 21 CFR Part 11
assessment, Data Integrity Assessment, Configuration Specifications, Design
specifications.Participate or lead investigation, where possible related to
discrepancies identified during qualification activities· Review & approve SOPs, Deviations/Event,
CAPAs, Change Controls, Periodic Maintenance plans and user access request’s
etc..· Effective interfaces with internal and external
stakeholders to ensure effective communication· Align with company’s Quality Goal and Strategy
to set the Quality Goal, as well as monitor result and employee performance· Provide guidance to operation personnel
regarding commissioning, qualification and validation. Work with the team on
continuous improvement activities.· Comply with company requirements on EHS· Perform other tasks as assigned by QA departmentRequirements· Minimum bachelor’s degree in biology,
biotechnology, or relevant discipline· Minimum 6 years of QA experience in the
biotech/pharmaceutical industry, preferable in vaccine or biologics or
commercial product experience, CDMO experience also preferred but not required.· Good understanding of cGMP requirements, GCPs,
GLPs, GAMP and Part 11 compliance as applied to quality assurance,
qualification of systems and validation of biotech/pharmaceutical manufacturing
processes· Excellent knowledge of validation principles· Thorough working knowledge of regulations and
industry best practice affecting product quality.· Familiar with questions and challenges in audits
and regulatory inspections.· Experience of working effectively in a
fast-paced environment· Demonstrated problem solving and facilitation
skills in day-to-day practices.· Excellent written and oral communication skills,
able to effectively interact cross-functionally and across all levels of the
organization.