Senior Quality Assurance Operations
Senior Quality Assurance Operations
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Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 QA Operations role will lead Quality Assurance activities Research & Development Division facility in Dunboyne. The 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
Lead facilitate and participate daily on crossfunctional 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 incoming 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 required
- Assist 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.
Requirements
Educational and Experience Requirements
- Degree qualification (Science/Quality/Technical).
- 810 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 PASX 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.
Educational and Experience Requirements Degree 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.
Education
Educational and Experience Requirements Degree 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 und
Employment Type
Full Time
