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Sr QA Associate

  • Type Contract
  • Salary competitive
  • Location Breda, North Brabant
  • Sectors Pharma & Biotech

Currently were are recruiting for an Sr. Associate QA for my key client in Breda. Great opportunity for expand your career in the life sciences! I am seeking a candidate who will act as a first point of contact in case of production queries (quality related) during packaging and labelling operations. It will be a one (1) year contract to start. Let me know if you are interested, I'd be happy to provide you with more information. s.kolks(at)realstaffing.com or 020 255 1588

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 2 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 English language.

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)