- 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.
- To provide QA guidance and support in the production area at ABR;
- To perform batch record review of batches assembled, packaged and labeled at ABR and contract manufacturers;
- To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
Position Specific Tasks:
- Provide daily guidance and support to Production staff in regards 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 labeling 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 labeled at ABR and contract manufacturers in preparation for disposition by QP;
- Act as author for operational SOP's and Work Instructions;
- Review of operational SOP's and Work Instructions;
- Review and approve class I Non Conformances;
- Initiate and own QA Non Conformances as needed;
- Approve Maximo Work Orders;
- Review and approve test protocols before use in production;
- Perform GMP compliance checks in production;
- 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.
- The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent;
- MBO or Bachelor's degree in 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;
- Fluent in Dutch and English language.
Over de werkgever
An international organization in the Breda area.
Uren per week:
It is a full-time position, 40 hours per week. This job is 5 working days (mon-fri), in 3 shift operation;
- Early: 06.30-15.00 every other week;
- Late: 14.30-23.00 every other week;
- Night: 22.30-07.00 for now every 8 weeks