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Quality Assurance Manager / QA Manager

Eingestellt von Advance Resourcing Ltd

Gesuchte Skills: Support, Client

Projektbeschreibung

Job Summary:

Minimum 12 month contract to start ASAP paying competitive hourly rate.
Requirements:

Title: Quality Assurance Manager / QA Manager

Location: Surrey

Job Accountabilities:

The QA Manager provides support to the Pharmaceutical and Consumer businesses and associated Support Services (and may focus on particular businesses as appropriate) by driving compliance with ethical rules, regulations and operational excellence, with a focus on:

Country quality oversight for medical activities that span the different Business Units and Support Services. Performing assigned key responsibilities relating to SOPs, Procedures, Training and Record Retention. Where appropriate, some responsibilities may be delegated to the QA Associate role
Supporting implementation and continuous improvement of the processes, systems and training required to maintain compliance and promote a culture of learning within the BUs. The QA Manager acts as a fundamental contributor to operational effectiveness that is essential to the delivery of high quality Client product and services.

Enable in country inspection readiness.

Job Content:

Quality Management

Development, implementation and maintenance of the local Quality Management System.
Liaise with the appropriate Stakeholders and Local Medical Management to develop in country quality
Ensure local implementation of global SOPs and ensure cascade of related communications.
Identify local regulatory requirements and ensure these are embedded in local and/ or global procedures.
Ensure effective local management of relevant local procedures.
Ensure local procedures are in compliance with applicable Client policies and procedures and regulatory requirements.
When requested provide input to draft Global/Area Policies/SOPs/Working Practices (WIs) and related training materials.

Medical-compliance related training

In collaboration with Support Services and relevant BU's;
Ensure that training requirements related to Medical and Compliance and key business-critical processes are included in the appropriate training curricula.
Ensure that local training curricula are maintained in line with internal Client standards.
Support local training for identified areas.
Facilitate local compliance reporting to Medical Management.
Subject Matter Expert on/ local management of Global Learning Management System.

Inspections / Audits

In collaboration with Support Services and other stakeholders; Support local inspections as defined by the local inspection action plan.
Provide support for internal audits as required.
Support and conduct local quality reviews to enable internal collection of data to drive relevant improvements in processes or training.
Responsibility for relevant CAPA implemented and followed up to closure as required, promoting audit and inspection readiness.

Records management, storage and archiving

The QA Manager will support the QA Associate in this activity and may have direct involvement where appropriate.
Working in collaboration with relevant Stakeholders, manage the local records management policy for local GxP documents, including regular review of retention schedules.
Ensure training of archivists on local policy and procedure to ensure inspection readiness of archived documents.

Quality Awareness

Ensure sound knowledge of regulatory requirements across Business Units and Support Services where appropriate.
Interact with internal and external networks
Demonstrate value proposition of quality and compliance to internal and external stakeholders.

Job Knowledge, Skills and Experience:

Graduate in a life science, information/knowledge management or relevant subject
Member of Research Quality Association (RQA) desirable
Knowledge and understanding of Quality systems, processes, audit and inspection
Post-graduate qualifications in relevant subject matter and/or IRCA Auditor Certification desirable
Thorough knowledge of ICH GCP, GxP, FCPA and related local regulations
Good knowledge of relevant local advertising Codes of Practice and guidelines
Participation in local process development, implementation, and delivery of training
Strong communication and interpersonal skills
Strong influencing and networking skills
Ability to understand laws, codes and policies and the need to translate into practical, workable procedures and clear guidance for all involved.
Understanding of pharmaceutical marketing, regulation, clinical trials, pharmacovigilance

Appreciation of the reputation of the industry and an understanding of how to protect Client's reputation

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email

If this role is not what you are looking for and you have experience in or are looking to enter the pharmaceutical, pharmacy, biochemical or other scientific fields, please still contact us anyway because listed here on BMJ are only a selection of the many vacancies we have available.

Keywords:
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Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Advance Resourcing Ltd

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