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 points 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 to 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview
This 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 Accountabilities
1. Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones.
2. Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
3. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility.
4. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
5. Complete QA operational duties related to product disposition including incoming material release and the performance of detailed review of eBR prior to QP release.
6. Evaluate new and prospective regulatory guidance and industry best practices and determine impact on Quality systems, identifying and implementing appropriate updates where required.
7. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
8. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
9. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
10. Participate in and support risk management activities in line with relevant guidance and best industry practice.
11. Assist in the execution of the internal audit program including the performance of audits as required.
12. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
13. Ensure the escalation of compliance risks to management in a timely manner.
Requirements
1. Degree qualification (Science/Quality/Technical).
2. 8-10 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
3. Project Manager capability with significant understanding of Operations.
4. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
5. Strong written and verbal communication skills.
6. Ability to think logically and be proactive under pressure.
7. Ability to work as part of a team and on own initiative in a constructive manner.
8. Strong attention to detail and precision in preparing and reviewing GMP documentation.
9. Experience in quality management systems such as Veeva, SAP, PAS-X etc.
10. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
11. Experience in direct interactions with regulatory agencies during site inspections.
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