QA Compliance Officer - pharmaceutical

DPS Alban Technical Limited
£39k - £40k pa + GENEROUS ALLOWANCE !
11 Nov 2017
16 Nov 2017
Contract Type
Full Time

QA Compliance Officer

6 month fixed contract


40k PLUS 16.5% allowance on top!
Our client a large pharmaceutical client is seeking a QA Compliance Officer for a 6 month contract. The main responsibilities will be to ensure 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.

You will also be responsible in Liaising 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 . Also, 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.

Other duties include (but not limited to)-

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 Bard Quality Management team and Bard 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 efficacy.

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

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