QA expert – Belgium

Introduction

Q-People provides targeted solutions in Quality and Compliance projects within Life Sciences, from Pharmaceutical and Biotech to API and Medical Device Production. Training, mentoring and coaching of talent within the Life Sciences sector is our strength. We don’t want specialist knowledge or talent to go to waste. WE PUT PEOPLE FIRST!

Our expert are active in:
1. Validation or qualification
2. Process engineering
3. Product development
4. Quality control projects
5. Quality assurance projects (analyst, project engineers)
6. Project Management in general.

Organization

Q-People

Function

Responsibilities:

• You are responsible for quality by monitoring and ensuring that processes and actions are carried out according to the applied cGMP quality standards:
• You follow written documents such as procedures, protocols and reports concerning the quality systems of other departments;
• You provide QA support and supervision for deviations, change control, CAPA and validation activities
• You will manage and coordinate activities related to deviations and CAPAs
• You manage and coordinate the continuous improvement of deviations and CAPAs and ensure the optimisation of all processes in terms of compliance and efficiency
• You participate in the analysis of quality trends
• You ensure that all major issues impacting the quality system are taken into account, managed and addressed in the action plans

Quality governance:

• Facilitation of quality governance meetings
• Managing the quality review of the new metrics file and providing technical support to extend the metrics for process owners.
• Facilitation of quality management review (QMR) meetings.

Deviation handling:

• You evaluate written events (deviations, OOS / OOL);
• You are responsible for the correction and approval of these procedures, protocols and reports;
• You are responsible for the correction and authorisation of these procedures, protocols and reports; You take care of batch records and laboratory records.
• You participate in various projects related to risk analysis, qualification and validation.
• You will be responsible for carrying out risk analyses and certain corrective and preventive measures (CAPAs)
• You follow up changes via Change Control
• You follow up on initial and routine validations and qualifications
• You participate in or supervise quality-related projects.

Complaints:

• Processing and documenting complaints.

Requirements

• Master’s or Bachelor’s degree in a relevant field, e.g. pharmacist, bio-engineer or you have achieved a similar level through experience ;
• At least 2 years of relevant experience in GMP.
• You are familiar with many quality tools (Risk Analysis, Fishbone, 6M, 5S…)
• You are able to work in French or Dutch and English

Offer

– The opportunity to co-create the Q-People strategy;
– A career plan and an individual coaching;
– Challenges related to your expertise and ambition ;
– Being part of our community of Q-Consultants and benefit from advice and support from peers;
– Funny moments: team buildings, afterworks, events, etc. ;
– Our Q-Academy offers an broad training programme (hard&soft skills) to strengthen your knowledge and develop your skills;
– A permanent contract and an attractive salary package (13th month pay, hybrid car, petrol card, net allowance, meal vouchers, group insurance, hospital insurance, etc.).

Application

Ana Pardo Pons | Talent Partner
[email protected]
Place de l’Université 16 | Louvain-la-Neuve

 

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