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.OverviewThis role is a key member of the quality team ensuring the site has
a strong operational compliance focus which is aligned with the principles and
expectations of cGMP regulations. The role will be responsible for maintaining
cGMPs for assigned areas in conformance with policies and in compliance with
cGMPs and Health Agency regulations and all other applicable governing
regulations. The Quality Assurance Operations, will have
fulfilled the educational requirements for this role and have the necessary
experience within an FDA/EMEA regulated environment. The Quality
Assurance Operations, will provide
quality support to the site, including training and guidance on the
interpretation and implementation of company Guidelines / Policies and
regulatory requirements, as required. Key AccountabilitiesLead, facilitate and
participate daily on cross-functional teams to collaboratively actively to
address compliance issues and achieve project milestones.Participate in investigations and risk
assessments related to deviations/ complaints and changes, ensuring
appropriate actions are implemented timely.Provide QA review and approval of Change
Controls, Deviations/CAPAs, SOPS and related documentation for compliance
to GMP and site requirements at the facility.Provide QA oversight to the
qualification/validation, technical transfers, regulatory approvals and
commercial/clinical operations at the facility.Complete QA operational duties related to
product disposition including in-coming material release and the
performance of detailed review of eBR prior to QP release.Evaluate new and prospective regulatory
guidance and industry best practice and determine impact on Quality
systems, identifying and implementing appropriate updates where required.Assist in the development of training
curricula and records for the QA Operations Group, providing SME training
on Quality Assurance SOPs as requiredAssist in the creation and maintenance of QA
policies, SOP’s and reports in line with site requirements.Support an environment of continuous
improvement by identifying and implementing efficiencies and quality
improvements.Participate in and support risk management
activities in line with relevant guidance and best industry practice.Assist in the execution of the internal audit
programme including the performance of audits are required.Work collaboratively to foster strong
relationships with management and colleagues and to drive a safe and
compliant culture.Ensures the escalation of compliance risks to
management in a timely manner. RequirementsEducational and Experience RequirementsDegree qualification (Science/Quality/Technical).8-10 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the
Biological and/or pharmaceutical industry.Project Manager capability with significant
understanding of Operations.Demonstrated experience in QRM,
Investigations, Problem solving as a Quality SME.Strong written and verbal communication
skills.Ability to think logically and be proactive
under pressure.Ability to work as part of a team and on own
initiative in a constructive manner.Strong attention to detail and precision in
preparing and reviewing GMP documentation.Experience in quality management systems such
as Veeva, SAP, PAS-X etc.Demonstrated knowledge and application of
industrial regulations including those of FDA, HPRA, EMEA and other
authorities related to Biologics and/or Pharmaceuticals.Experience in direct interactions with
regulatory agencies during site inspections.