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Waar?

SR. Associate QA

Solliciteer

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.

Vaardigheden

  • 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.

Scholing: HBO/MBO/

Over de werkgever

An international organization in the Breda area.

Uren per week: 40

Contract:

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 expected it will be more frequent in near future (e.g. every 4 to 5 weeks) .


Vast,

YER Nederland

Ken Van Mierlo
YER Nederland
Contactgegevens

Ken Van Mierlo
+31 (0)6 114 102 76
kenvanmierlo@yer.nl

YER Nederland
Hogehilweg 16
1101CD,  Amsterdam Zuidoost

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