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AX-7202 QA Officer

AXESS Ltd Published: 13th February 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7202

 

JOB SUMMARY

QA Officer role at a Global specialty-driven biotechnology to manage batch record reviews, authoring PQRs, building quality metrics, writing SOPs and processes and participating in other quality-based projects.

 

BACKGROUND

Global specialty-driven biotechnology group

Offer products in oncology and endocrinology amongst others

Strong pipeline

Launches anticipated over the next 2 years

Excellent potential for career development within the QA group

Flat structure with every role in the QA group offering high exposure to company senior leadership team

 

PRIMARY DUTIES:

Responsible for the provision of QA support to the External Manufacturing organisation team for all Drug Substance and Drug Product manufacturing and testing activities performed at Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).

Provide direct support to the QA Managers in the management of the day today aspects of the QA Department, including batch record reviews, document management, PQR Authoring and participating in quality-based projects.

Handle complaints and deviations in line with company procedures, coordinating with subcontractors

Providing QA Support and assist in implementing Quality systems, metrics and documentation.

Generate SOPs, KPIs and Quality Management Reivews

Provide support on product manufacturing and testing to Third-Parties and to the Technical, Regulatory CMC functions within company’s External Manufacturing Organisation.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Degree in a Life Sciences discipline, ideally in Pharmacy, Chemistry, Microbiology or Engineering

Pharmaceutical Quality experience with experience in a “virtual” manufacturing environment being advantageous.

CMO experience advantageous

 

BENEFITS:

Corporate

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.

To apply, please click the APPLY ONLINE button

 

KEYWORDS:

QA Officer, quality assurance officer, Quality Assurance, QA, CMO, CMOs, contract manufacturing organisation, CMO, Quality Assurance  Manager, Manager QA GMP, quality co-ordinator, quality review, Contract Testing Laboratories, CTL, Product Quality Review, change controls, External Manufacturing Organisation, TrackWise, risk evaluation, risk management, CAPA, audit, GxP, QMS, Quality management, Compliance, quality assurance, global QA, global quality assurance, Manufacturing, QA, audits, critical deviations, change control, risk assessment,  root cause analysis, QA Supply chain, QA logistics, quality compliance,  global quality, global QA, batch record review, batch release, document management, SOP writing

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

 

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