Senior Associate QA (GMP) (

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) in 3 shifts, on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension.

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.

Main Responsibilities of the role

• To provide QA guidance and support in the production area at ABR.
• To perform batch record review of batches assembled, packaged, and labelled at ABR and contract manufacturers.
• To 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.

Requirements

• MBO or Bachelor’s 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.
• Understanding and application of principles, concepts, theories, and standards of technical/scientific field.
• Specialized 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.
• 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, categorizes, evaluates, reconciles, reports, and resolves data integrity issues.
• Interprets generally defined practices and methods.
• 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 timeframes and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems.
• Contributes to work 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 area of expertise.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607.

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