Quality Assurance Specialist

Panda International; Breda; On-site; EUR 60,000 - 90,000; Full time

Job summary

Panda International is seeking a Quality Assurance professional to support production operations within a regulated pharmaceutical environment. You will work with Production, Warehouse, Maintenance and Engineering to ensure packaging and labelling meet quality and compliance standards.

You will review batch records, provide guidance on SOPs, and act as a first contact for quality queries during packaging/labeling.

Qualifications

• Three years of QA/manufacturing experience in pharma or medical device industries.
• Experience with batch record review and investigations.
• Knowledge of GMP, GDP and/or GCP and interpreting these requirements.

Responsibilities

• Provide QA guidance within the production area and ensure SOP adherence.
• Perform batch record reviews for on-site assembled, packaged and labelled batches.
• Review and approve deviation records and initiate QA deviations when required.
• Author and review operational SOPs and Work Instructions.
• Support GMP training for QA and Production staff and participate in QA projects.
• Prepare weekly and monthly performance metrics and maintain departmental dashboards.
• Build relationships with Production, Warehouse, Maintenance, Engineering and QA management.

Skills

Quality Assurance

GMP/GDP/GCP knowledge

Documentation & records

Education

MSc or BSc in Pharmaceutical Sciences or Life Sciences

Job description

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.
• 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 elevate 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.
• 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.

NOTE: This is a shift role.

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 night shifts
• Four consecutive days off

This cycle will repeat continuously.