Description
A Biologics and Pharmaceutical client based in Belgium are looking for a Quality Assurance (QA) Specialist to focus on their product release and batch release quality checks. The contract is looking to be 10 months with an immediate start. The client requires an experience Quality Assurance individual who has excellent problem solving, multi-tasking, and team playing skills.Responsibilities:
1) Follow-up of product related:
Change control
Failure investigation
Deviations (planned and unplanned)
Cleaning validation of dedicated equipment
Process validation (protocols and reports)
Stabilities (protocols and reports)
CAPA and action plans
2) Review of batch record:
Review of master batch records and specifications
Authoring and follow up of Product Quality Review
Review and authorization of relevant SOPs
3) Follow up of RA commitments
4) authorisation of tech transfer towards manufacturing (protocol and report)
5) Authorisation of reworks
6) Act as back up for other team QA Officers and Assistants according to Manager instructions
7) Assist Manager to achieve team objectives
Requirements:
Around 5 years' experience in Change management and quality analysis
Has demonstrated a fact based decision making process, accountability and delivering attitude
Knowledge of worldwide regulations pertaining to GMP
Essential soft skills:
Multi-tasking
Detail oriented
Problem solving
Excellent interpersonal relationship skills
Excellent oral and written communication skills
Well-developed sense of discretion and ethics
Excellent team player attitude
Stress resistant
Fluent in English
Beneficial soft skills:
Cross-functional/cross-border team experience
Autonomous
Flexible
Software Dreamweaver