Senior Associate QA (GMP) (33114)

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.

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@orioneng.com or contact Tim on 0044 7593448607.

#opportunity #multinational #pharmaceutical #biotechnology #senior #associate #QA #qualityassurance #gmp

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.