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Date Added: Wed 25/01/2023

Qualified Person

Slough, SL1, UK
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Company: INDEX

Job Type: Permanent, FullTime

Description
Summary: Work with the Principle QP (Qualified Person) to maintain and improve all activities directly and indirectly relating to QP certification and batch release. Completion of all core GMP and relevant training and maintaining own training file and closing out training file audit actions. Acting as a point of contact for queries relating to QP certification and batch release. Support Senior Quality Associates and QA (Operations) Team Leader roles when workload, department or site needs dictate. Key responsibilities: Provide QA support to initiate, manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs. Provide QA/GMP SME expertise to assist non-QA functions with progressing major and critical compliance issues through the QMS processes. Represent QA (Operations) at Manufacturing and Quality Control LQC's and Team Times. Actively suggest, initiate, participate and contribute to QMS process improvements initiatives and projects. Actively develop, mentor, train and enforce a site GMP culture within Operations. Support regulatory and customer audits of the Operations areas and processes. Utilizing knowledge of GMP and quality processes to advise non-QA functions on compliance issues via interaction with the relevant personnel. Apply cGMP regulations consistently. Expand compliance knowledge base and mentor others to expand on-site compliance knowledge. Utilizing knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement. Actively manage assigned areas of the QMS with full ownership for maintaining compliance status. Support site QA leaders and other QPs with timely and reliable information to support site QMS management, decision processes and strategy development. Engage in self-inspection of the site QMS. Act as an ambassador for client and QA in all interactions with customers. Act as a single point of contact in interactions between QA and internal client functions and external customers and third parties as required. Key Requirement: Minimum Bachelor?s degree in Science or QA discipline. Extensive hands on work experience as a QP on a manufacturing license. Experience in manufacturing of biological products. Excellent technical and scientific judgement. Ability to interpret and translate GMP guidelines into effective processes and procedures. Experience of MHRA, FDA and other regulatory inspections. Previous GXP and QMS process design, implementation, and management and utilization experience. Ability to work in team and solo capacity. Significant experience in risk management and project management. Strong auditing experience.

Work with the Principle QP (Qualified Person) to maintain and improve all activities directly and indirectly relating to QP certification and batch release.
Completion of all core GMP and relevant training and maintaining own training file and closing out training file audit actions.
Acting as a point of contact for queries relating to QP certification and batch release.
Support Senior Quality Associates and QA (Operations) Team Leader roles when workload, department or site needs dictate.

Key responsibilities:
Provide QA support to initiate, manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs.
Provide QA/GMP SME expertise to assist non-QA functions with progressing major and critical compliance issues through the QMS processes.
Represent QA (Operations) at Manufacturing and Quality Control LQC's and Team Times.
Actively suggest, initiate, participate and contribute to QMS process improvements initiatives and projects.
Actively develop, mentor, train and enforce a site GMP culture within Operations.
Support regulatory and customer audits of the Operations areas and processes.
Utilizing knowledge of GMP and quality processes to advise non-QA functions on compliance issues via interaction with the relevant personnel.
Apply cGMP regulations consistently.
Expand compliance knowledge base and mentor others to expand on-site compliance knowledge. Utilizing knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement.
Actively manage assigned areas of the QMS with full ownership for maintaining compliance status. Support site QA leaders and other QPs with timely and reliable information to support site QMS management, decision processes and strategy development.
Engage in self-inspection of the site QMS.
Act as an ambassador for client and QA in all interactions with customers.
Act as a single point of contact in interactions between QA and internal client functions and external customers and third parties as required.

Key Requirement:
Minimum Bachelors degree in Science or QA discipline.
Extensive hands on work experience as a QP on a manufacturing license.
Experience in manufacturing of biological products.
Excellent technical and scientific judgement.
Ability to interpret and translate GMP guidelines into effective processes and procedures. Experience of MHRA, FDA and other regulatory inspections.
Previous GXP and QMS process design, implementation, and management and utilization experience.
Ability to work in team and solo capacity.
Significant experience in risk management and project management.
Strong auditing experience.

Index Recruitment Ltd is acting as an Employment Business in relation to this vacancy.

"Due to the high volume of applications, we currently receive, we are unable to respond to all candidates. If you do not hear from a Consultant within 5 working days unfortunately you have been unsuccessful on this occasion
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