AX-7202 QA Officer
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.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
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
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
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button
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