QA Validation Senior Specialist
Posted on Apr 24, 2021 by Elevate Direct
QA Validation Senior Specialist
Reporting to the QA Director, the QA Validation Senior Specialist will be responsible and accountable for developing the QA validation framework, local policies and procedures and ensuring compliance to corporate, legislative and local practices for the review and approval of all qualification/validation documentation and QA related activities to the release of facility, utility and equipment for GMP production. The QA validation specialist will also ensure a process is in place for periodic review and ensuring a sustainability programme exceeds demonstrating compliance to processes and change control.
The incumbent provides leadership and oversight of the QA Validation process on site. Responsible for preparing the quality review and ensuring all approvals of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
Develop, write, review, and approve SOPs and controlled documents to support site validation activities and in accordance with client policies.
Ensure all equipment and processes are safe, effective, and qualified in compliance with industry standards and regulatory expectations.
Lead the Validation Review Board (VRB) and provide overall quality leadership and oversight for key functional areas (ie, PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations. Lead the team providing clear expectations regarding validation standards. Report monthly validation KPIs and metrics and ensure opportunities for improvement are identified and actioned accordingly.
As senior specialist actively participates in the New Product Introduction (NPI) and technology transfer process and ensure all associated protocols are conducted and in place in line with project timelines and impact assessments. Provide support to team members for more complex processes and decisions. In addition, ensure compliance to regulatory, China and local protocols.
Lead by example and ensure associated risk assessments are conducted in line with site expectations and provide a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Lead a team of validation engineer and project engineer and provide support and guidance regarding priorities and objectives. Set goals and objectives as per the associated performance management guidelines and ensure feedback and coaching opportunities are provided timely to employees to ensure optimum performance.
Liaise actively with other functional areas and provide leadership and support to ensure standards are met. Ensure corrective action/preventative action measures are put in place to drive improvement.
Be lead representative for internal and external audits regarding validation processes and protocols. Represent the organisation in more complex risk and impact assessments.
Perform all activities in compliance with client safety standards and SOPs.
Participate in other projects/duties as assigned.
B.Sc or B.Eng in a Scientific or Engineering related discipline preferred.
Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Strong level of experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Previous experience leading an established validation team, working in a green field environment advantageous.
Experience working in Quality Assurance role in a GMP Life Science environment.
Demonstrated understanding of principles of Validation and New Product Introduction and strong knowledge of Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
Strong knowledge of GxP regulations (eg, EU-GMP Guideline, Annex 11/15, SFDA)
Strong leadership competencies with demonstrated management skills.
Strong organisational, communication, coordination, and meeting facilitation skills.
Excellent interpersonal, verbal, and written communication skills.
Strong critical thinking skills and troubleshooting to drive improvement and build opportunities.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and your colleagues.
Engage cross functionally in conjunction with a site-based team.
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