Senior Associate QA (GMP)

Location Breda
Discipline: Biotechnology, Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 16888
Published: about 1 month ago

For one of the biggest biopharmaceutical companies, we are looking for a Senior Associate QA (GMP). We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. The company is located in Breda and offers flexible remote work.

 

IMPORTANT INFO:

Please note! This is a 3-shift job, 100% commitment is needed.

  • Early shift: 06.30 - 15.00
  • Late shift: 14.30 - 23.00
  • Night shift: 22.30 - 07.00

 

Objectives:

  • Provide QA guidance and support in the production area at ABR.
  • Perform batch record review of batches assembled, packaged, and labelled at ABR.
  • Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management, and the Qualified Person.
  • Provide daily guidance and support to Production staff regarding 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 labelling 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 labelled at ABR in preparation for disposition by QP.
  • Perform GMP compliance checks in production.
  • Review and approve deviation records.
  • Initiate and own QA deviations as needed.
  • Act as author for operational SOP’s and Work Instructions, as needed.
  • Review of operational SOP’s and Work Instructions, as needed.
  • 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.

 

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 the work of 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.

 

Minimum Requirements:

  • Master’s degree in Pharmaceutical/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.

 

Location: Breda

Start date: ASAP

Duration: 1 year + extension

 

ORGANISATION AND OFER

You will join growing and innovative organization and will be involved in successful projects with customers all over the world. You are part of a multi-disciplinary team that is continuously creating value for their clients. This is a unique opportunity to develop yourself and to grow within the company. You can expect an attractive salary, benefits, and a lot of growth within this organization.

 

INTERESTED? Reach out to Sayf Idais for more information by contacting +31 (0)20 20 44 502 or s.idais@panda-int.com