For one of the biggest biopharmaceutical companies, we are looking for a Senior Associate QA (GMP). We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. The company is located in Breda and offers flexible remote work.
Please note! This is a 3-shift job, 100% commitment is needed.
- Early shift: 06.30 - 15.00
- Late shift: 14.30 - 23.00
- Night shift: 22.30 - 07.00
- 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 regarding 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.
- 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 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 area of expertise.
- Master’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.
- Manufacturing and/or Quality analytical processes and operations.
Start date: ASAP
Duration: 1 year + extension
ORGANISATION AND OFER
You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients. This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary, benefits, and a lot of growth within this organization.
INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org