Quality Assurance Operations Employee (m/f/d) at EVER Pharma Jena GmbH
berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

21 Dec, 26

Salary

90000.0

Posted On

22 Sep, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

This is what you can expect

  • Support in implementing the on-site quality assurance system (quality oversight) in the areas of manufacturing, packaging and quality control and
  • Maintaining compliance standards
  • Ensuring and optimizing the batch record review process as a prerequisite for drug release
  • Conducting quality oversight of the validation processes of the aseptic manufacturing process (aseptic process simulation) in collaboration with the production team and the QS qualification/validation team.
  • Handling of deviations and OOX during production and quality control
  • Creation and review of trend analyses
  • Implementation of projects to improve the GMP standard within the company
  • Maintenance and review of quality assurance GMP documents for production areas (e.g., SOPs, trend reports, risk analyses)
  • Support for production areas regarding GMP issues

The position is limited to one year.

What you bring with you

  • Completed university or technical college degree in a natural science field, or vocational training with appropriate further education (master craftsman, technician)
  • Ideally, initial professional experience in the pharmaceutical industry.
  • Knowledge of quality management and relevant pharmaceutical regulations is an advantage.
  • Good English skills, both spoken and written.
  • Reliability, organizational skills and the ability to work independently
  • Strong cooperation and communication skills, teamwork skills, resilience, assertiveness

We offer this

  • An interesting and varied role in a responsible, internationally successful company that invests in the future for the long term.
  • Job security through a stable order situation in a growth industry
  • A comprehensive, individualized onboarding process with regular feedback sessions.
  • An attractive compensation model and development opportunities
  • A positive company culture with a lot of collegiality and team spirit in a motivated and professionally experienced team.


Responsibilities

This is what you can expect

  • Support in implementing the on-site quality assurance system (quality oversight) in the areas of manufacturing, packaging and quality control and
  • Maintaining compliance standards
  • Ensuring and optimizing the batch record review process as a prerequisite for drug release
  • Conducting quality oversight of the validation processes of the aseptic manufacturing process (aseptic process simulation) in collaboration with the production team and the QS qualification/validation team.
  • Handling of deviations and OOX during production and quality control
  • Creation and review of trend analyses
  • Implementation of projects to improve the GMP standard within the company
  • Maintenance and review of quality assurance GMP documents for production areas (e.g., SOPs, trend reports, risk analyses)
  • Support for production areas regarding GMP issues

The position is limited to one year.

What you bring with you

  • Completed university or technical college degree in a natural science field, or vocational training with appropriate further education (master craftsman, technician)
  • Ideally, initial professional experience in the pharmaceutical industry.
  • Knowledge of quality management and relevant pharmaceutical regulations is an advantage.
  • Good English skills, both spoken and written.
  • Reliability, organizational skills and the ability to work independently
  • Strong cooperation and communication skills, teamwork skills, resilience, assertiveness

We offer this

  • An interesting and varied role in a responsible, internationally successful company that invests in the future for the long term.
  • Job security through a stable order situation in a growth industry
  • A comprehensive, individualized onboarding process with regular feedback sessions.
  • An attractive compensation model and development opportunities
  • A positive company culture with a lot of collegiality and team spirit in a motivated and professionally experienced team.

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