For one of our clients, located in Breda (The Netherlands) , we are currently looking for a "Senior Associate QA (GMP)".
Job Description
We're looking for an outgoing, multi-tasking medior with strong communication skills and the ability to work under pressure. GMP experience is a plus.
Please note: This is a 3 shift job. Early shift: 06.30 - 15.00 Late shift: 14.30 - 23.00 Night shift: 22.30 - 07.00 - 100% commitment is needed.
The Objectives:
- To provide QA guidance and support in the production area.
- To perform batch record review of batches assembled, packaged and labeled at the production area and contract manufacturers.
- To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.
Responsibilities
- 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.
- Review of operational SOP's and Work Instructions as needed
- Review and approve deviation records
- Initiate and own QA deviations as needed.
- 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
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
Requirements
- Understanding and application of principles, concepts, theories and standards of technical/scientific field
- 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
- 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
- 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 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.
Benefits
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16243
