Senior Talent Acquisition Specialist at Independent Solution | Hiring for Pharma & Biotech | Expert in Global Sourcing
Job Purpose:
* The role is a vital member of the quality team, responsible for ensuring the site maintains a strong focus on operational compliance in line with cGMP regulations. The position will oversee the adherence to cGMPs in designated areas, ensuring alignment with company policies and compliance with cGMPs, Health Agency regulations, and all other relevant governing regulations.
* The Quality Assurance Operations, BioNX will meet the educational qualifications for the role and possess the necessary experience in an FDA/EMEA regulated environment. This role will also provide quality support to the site, offering training and guidance on interpreting and implementing company guidelines, policies, and regulatory requirements as needed.
Key Accountabilities:
* Lead, facilitate and participate daily on cross-functional teams to collaboratively 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 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 as 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.
Educational and Experience Requirements:
* 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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance, Science, and Product Management
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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