Senior Associate QA (GMP) Breda • Talentmark

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We are looking for an outgoing, multi-tasking person with strong communication skills and the ability to work under pressure. GMP experience is a plus.

Please note! This is a 3-shift job with the following shift structure:

• One week night shift
• One-week late shift
• One-week early shift
• One-week late shift
• One-week early shift

Early shift: 06.30 – 15.00; Late shift: 14.30 – 23.00; Night shift: 22.30 – 07.00.
100% commitment is needed.

Objectives:

• Provide QA guidance and support in the production area at ABR.
• Perform batch record review of batches assembled, packaged, and labelled at ABR.
• Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person.
• Provide daily guidance and support to Production staff in regard to compliance with Standard Operating Procedures and Work Instructions.
• Act as a first point of contact in case of production queries (quality related) during packaging and labelling operations.
• Review and approve batch production record data entries before production activities take place.
• Perform finished product checks during (commercial) production runs.
• Compile and review batch records for lots assembled, packaged, and labelled at ABR in preparation for disposition by QP.
• Perform GMP compliance checks in production.
• Review and approve deviation records.
• Initiate and own QA deviations as needed.
• Act as author for operational SOP’s and Work Instructions, as needed.
• Review of operational SOP’s and Work Instructions, as needed.
• Assist in development and delivery of GMP training activities for QA and production staff.
• Participate in QA production related projects, as needed.
• Assist in various investigations, as needed.
• Assist in ABR projects and improvement efforts, as needed.
• Responsible for preparation of weekly/monthly metrics.
• Own and maintain departmental performance boards.

Knowledge:

• Understanding and application of principles, concepts, theories, and standards of technical/scientific field.
• Specialised knowledge within own specialty area.
• Deepens technical knowledge through exposure and continuous learning.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

Problem Solving:

• Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
• Ensures compliance within regulatory environment.
• Develops solutions to technical problems of moderate complexity.
• Screens, categorises, evaluates, reconciles, reports, and resolves data integrity issues.
• Interprets generally defined practices and methods.

Autonomy:

• Works under general direction.
• Work is guided by objectives of the department or assignment.
• Refers to technical standards, principles, theories, and precedents as needed.
• May set project time frames and priorities based on project objectives and ongoing assignments.
• Recognises and escalates problems.

Contribution:

• Contributes to the work of group/team by ensuring the quality of the tasks/services provided by self.
• Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
• Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
• Establishes working relationships with others outside the area of expertise.

Minimum Requirements:

• MBO or BSc degree in Pharmaceutical/ Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Experience with Manufacturing and/or Quality analytical processes and operations.
• Fluent in English language.