Quality Assurance Consultant
- Contract Type
For our client we are looking for a candidate with a high interest in quality, willing to develop her/his career into this area.
Within the Pharma QA department, we are looking for a quality expert External Products / EU release for a full-time job on a temporary basis. The general objective of the External Product / EU release quality expert is to monitor the quality systems in the production environment in order to ensure the efficacy and safety of the medicines and compliance with the legal requirements.
- You are responsible for dealing with deviations within the External Products / EU release Products department with specific focus on the lines assigned to you. In order to substantiate the decisions in a well-founded way, cooperation and consultation with the production department, technical services, labs and other parties involved is a 'must', in order to obtain a complete and complete overview. You ensure that root cause analysis, impact analysis and corrective and preventive actions are carried out thoroughly and well documented.
- You are jointly responsible for the release process of External Products / EU release Products. As such, you are responsible for reviewing and assessing batch-related documents of the externally delivered sterile bulk products and the internally executed packaging activities. You are also responsible for the read-out and interpretation of the shipment data.
In order to ensure the continuity of the market supply and to avoid stock-out situations, communication and agreements with the production and planning department are very important. You are jointly responsible for identifying delaying factors, communicating them and carrying out periodic reporting.
- You carry out complaints research in collaboration with the various parties involved and responsible inspector. As such, you coordinate investigations with external parties for the bulk / product supplied and with the internal departments involved for the packaging activities in Beerse. You ensure that the complaints are conducted with sufficient depth and are documented according to the procedure. If corrective and / or preventive actions have to be carried out, you take an active initiative to start these and develop them in accordance to the agreements.
- You proactively contribute to improvement initiatives that guarantee the quality of the end product. Hereby, (s)he strives for a decrease in the number of errors in batch records, deviations and complaints by co-creating and supporting cause analyzes, follow-up and implementation of corrective and preventive action plan and evaluation of the achieved end result.
- You carry out control rounds and audits according to planned schedule. In order to maintain an overview throughout the various production levels, you will conduct QA rounds according to a detailed plan, taking into account the different cGMP aspects. The findings are described in a report and discussed with the departments involved. Cause analyzes and corrective actions that have been defined are followed up via the existing follow-up systems.
- You are partly responsible for the classification and archiving of the HAP and AP bundles and other quality-related documents in accordance with the applicable record retention procedure.
- You actively cooperate in the work consultation sessions within the Production department with the aim of increasing the quality and compliance awareness within these departments.
- You have a pharmacist / bio-engineering degree or equivalent based on work experience in the pharmaceutical sector.
- You attach great importance to quality and are constantly looking for continuous improvement.
- You have the ambition to work in the pharmaceutical industry
- You can work independently and take a decision in consultation with colleagues
- You are sufficiently resilient to substantiate a decision in relation to other departments (production, planning, ...)
- You can deal with time pressure
- You can work well in a team
- You are familiar with the lean principles
You are strong in communication with colleagues from other departments, other educational levels
- You have good PC knowledge
- You can read and write English
Benefits working for TalentSource:
- Dedicated Line Manager
- Monthly meetings with line manager
- Employee satisfaction survey - your feedback is important for continuous improvement
- Annual appraisals development planning
- Yearly team event
- New Year's diner
- Group and hospitalization insurance
- Electronic meal vouchers
- Internet reimbursement
If you have the experience needed for this position, please contact Julie Casteleijn, Consultant TalentSource Life Sciences Unit, and send your English CV in Word format to Julie.firstname.lastname@example.org.
Why TalentSource Life Sciences/CROMSOURCE:
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Clinical Development Consultant, Quality Assurance, Safety