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Job Details

QA Compliance Officer

Company: Hobson Prior
Location: Cambridgeshire
Reference: FC468291
Closing Date: 10 Dec 17
Type: Contract
Salary (£): On Application
Benefits: Dependent on Experience

Job Summary:

Job Title: QA Compliance Officer Department: Quality Responsible to: Compliance Manager/ QP

Requirements:

Job Title: QA Compliance Officer
Department: Quality
Responsible to: Compliance Manager/ QP

Broad Purpose of Job:
Ensures systems are established that enable the manufacture of medicinal products in accordance with current national and international legislation, relevant standards and guidelines and the relevant Manufacturing and Marketing Authorisations.

Liaises as necessary with stakeholders within the business, third party organisations and relevant Health Authorities to represent the Company interest, support in resolve Quality Compliance related issues and Preparing relevant reports

Supports the Compliance team in ensuring ongoing advice, guidance to the Company and its associates and supports in implementation of processes relating to legislation, compliance and batch release.

Specific Duties & Responsibilities:

Responsible for the generation of the Annual Product Quality Reviews of products manufactured and/or certified on site as per Company’s processes

Supports the Regulatory Affairs group on queries and topics concerning Quality and Licensing in different territories/countries under the guidance of Quality Management team and QPs.

Updates, maintains and reviews release specifications, shelf life specifications, systems and procedures within the company’s Quality System to ensure compliance with Marketing Authorisations and regulatory requirements.

Prepares and Updates Certificate of Analysis for regulatory submission to new territories

Prepares and updates Certificate of Analysis and Certificates of Conformances

Supports in Quality Risk Assessments relating to quality and compliance issues

Supports in GMP failure investigations in conjunction with the Production Management, communicating and monitoring the implementation of appropriate corrective / preventative actions.

Ensures effective communication, reporting and follow up of issues involving product quality, safety and efficiency.

Supports the company’s self-inspection programme and performs internal audits in support of this when required.

 

If this role is of interest please apply by either using the form below or you can contact me directly on 01892 612 612 frankie.cunningham@hobsonprior.com

OR

Apply here - applying is quick and easy on our new website

Apply for this job: QA Compliance Officer

Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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