Quality Assurance Engineer (Rodopi)

Posted Yesterday
2 Locations
In-Office or Remote
Junior
Biotech • Pharmaceutical • Manufacturing
The Role
Ensure calibration, qualification and validation of equipment, warehouses and production areas; prepare and control SOPs/TDRs and controlled layouts; monitor environmental conditions and maintenance; manage change controls, deviations, risk assessments; train staff on validation/qualification controls and ensure compliance with ISO 9001:2015 and EU cGMPs.
Summary Generated by Built In

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Quality Assurance Engineer to join the Quality Engineering & Qualification team in our Sapes premises.

As a Quality Assurance Engineer, you will keep a key role in all calibration / qualification activities of the site.


Requirements

More particularly:

What you’ll do:

  • Issuance of TDR and SOPs relevant to operation, maintenance, cleaning and validation/ qualification activities of areas and equipment
  • Compliance with legislation requirements regarding change controls, deviations, risk management related to equipment and areas
  • Ensure compliance to the Quality Management System according to ISO 9001:2015 and EU cGMPs
  • Responsible for the preparation and control of the controlled layouts of the plant and the warehouses
  • Responsible for issuance, conducting and monitoring of protocols for validation and / or qualification of equipment, warehouses and production areas
  • Keep a key role in project plans regarding new areas and equipment
  • Carry out validation and / or qualification of equipment, applications and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
  • Responsible for the training of production, warehouse and technical personnel related to the controls – measurements in regards to validation & qualification of equipment and plant areas
  • Monitor the environmental conditions of production, quality control and warehouse areas, as well as, utilities
  • Monitoring of maintenance activities of the facility and warehouses

Requirements

  • BSc in Engineering or relevant field
  • 1-3 years’ experience in an industrial environment is desirable

Job-Specific Skills

  • Excellent communication in English language (writing & speaking)
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Problem Solving Skills

Benefits

What you'll gain:

  • Involvement in a high-caliber, team-oriented and dynamic atmosphere
  • Exposure to challenging business issues and practices
  • Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin

Skills Required

  • BSc in Engineering or relevant field
  • 1-3 years' experience in an industrial environment
  • Experience in calibration, validation and/or qualification activities
  • Knowledge of ISO 9001:2015 and EU cGMP requirements
  • Excellent English communication (written and spoken)
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Problem solving skills
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The Company
1,600 Employees
Year Founded: 1969

What We Do

Pharmathen is a research-centered, pharmaceutical company focused on developing and marketing innovative generic products and complex drug delivery technologies, aiming to provide Life Cycle Management solutions.

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