Join a dynamic Quality Assurance team supporting production operations within a regulated pharmaceutical environment. You will work closely with Production, Warehouse, Maintenance, Engineering, QA Management and the Qualified Person to ensure packaging and labelling activities meet the highest quality and compliance standards.
Your responsibilities
- Provide QA guidance and support within the production area.
- Perform batch record reviews for batches that are assembled, packaged and labelled on-site.
- Establish effective working relationships with Production, Warehouse, Maintenance, Engineering, QA Management and the Qualified Person.
- Provide daily guidance to Production staff regarding compliance with SOPs and Work Instructions.
- Act as the first point of contact for quality-related queries during packaging and labelling operations.
- Review and approve batch production record entries before production activities take place.
- Perform finished-product checks during commercial production runs.
- Compile and review batch records in preparation for disposition by the Qualified Person.
- Perform GMP compliance checks within production.
- Review and approve deviation records.
- Initiate and own QA deviations when required.
- Author and review operational SOPs and Work Instructions.
- Assist with the development and delivery of GMP training for QA and Production staff.
- Participate in QA production-related projects.
- Support investigations, projects and continuous improvement initiatives.
- Prepare weekly and monthly performance metrics.
- Own and maintain departmental performance boards.
Knowledge and expertise
- Understanding and application of the principles, concepts, theories and standards within a technical or scientific field.
- Specialized knowledge within your own area of expertise.
- Commitment to deepening technical knowledge through exposure and continuous learning.
- Knowledge of relevant regulatory and industry considerations, compliance requirements and scientific developments.
Problem-solving capabilities
- Apply research, information-gathering, analytical and interpretation skills to problems of diverse scope.
- Ensure compliance within a regulated environment.
- Develop solutions to technical problems of moderate complexity.
- Screen, categorize, evaluate, reconcile, report and resolve data-integrity issues.
- Interpret generally defined practices and methods.
Autonomy and contribution
- Work under general direction, guided by departmental or assignment objectives.
- Refer to technical standards, principles, theories and precedents as required.
- Set project timeframes and priorities based on project objectives and ongoing assignments when needed.
- Recognize and escalate problems appropriately.
- Ensure the quality of your own tasks and services while contributing to the wider team.
- Support the completion of project and departmental milestones.
- Provide training and guidance to colleagues and act as a technical or scientific resource.
- Build effective working relationships with stakeholders outside your immediate area of expertise.
Minimum requirements
- MSc or BSc degree in Pharmaceutical Sciences, Life Sciences or a related field—or an equivalent combination of education and experience.
- Typically at least three years of relevant Quality Assurance or manufacturing experience within the pharmaceutical or medical device industry, including batch record review and investigations.
- Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP), with the ability to interpret and apply these requirements in mainly routine cases.
- Experience with manufacturing and/or quality analytical processes and operations.
- Fluent in English.
NOTE: This is a shift role.
The role currently operates on a 3-shift, 24/5 schedule. A transition to a 5-shift, 24/7 schedule is planned for 1 January 2027 at the earliest.
You must be willing and able to work the future rotating schedule:
- Two early shifts
- Two late shifts
- Two night shifts
- Four consecutive days off
This cycle will repeat continuously.
Interested? Send your CV to Beata at b.didomenico@panda-int.com or call +31202044502.