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Snr QA Associate

Netherlands, Netherlands

  • Salary: Dependent on experience
  • Job type: Interim/Contract
  • Posted: 10/09/2018
  • Contact name: Frankie Cunningham
  • Contact number: 01892 612612
  • Ref: 3605

Job description

Sr. Associate QA 

Expectations/scope/complexity: 

Knowledge: 

  • 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 

Problem Solving: 

  • 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 

Autonomy: 

  • 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 

Contribution: 

  • 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 

Objectives: 

  • 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 

Qualifications: 

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. 

Minimum Requirements: 

  • 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. 

Preferred Requirements: 

Fluent in Dutch and English language. 

***Note: This job is 5 working days (mon-fri), in 3 shift operation 

- Early: 0630-1500 every other week 
- Late: 1430-2300 every other week 
- Night: 2230-0700 for now every 8 weeks expected it will be more frequent in near future (e.g. every 4 to 5 weeks)

If this role is of interest please make an application by either completing the form below or contacting me directly on frankie.cunningham@hobsonprior.com or +44 1892 612 612