Quality Assurance Specialist

Over de functie

We are seeking an experienced Quality Assurance Analyst to be part of our Quality team. The Quality Assurance Analyst is responsible for ensuring timely and effective implementation of all company policies, procedures, and activities involved in assuring the quality of our products. Follows established standard operating procedures and regulatory requirements. Performs independent and collaborative tasks within a team environment. Supports manufacturing to ensure product and process quality. Provides support in creation of reports, protocols and SOPs. Demonstrates technical understanding of all quality systems.

MAJOR ACCOUNTABILITIES:

Candidate must demonstrate strong technical understanding of methodology and quality systems in a manufacturing environment. Specific duties for the position to include maintenance of investigating and correcting quality related issues such as Batch Release, Document Approval and Control, Investigation System including CAPA, Customer Complaints, Change Control, and cGMP Training.

Provides daily quality support under medium supervision.

Collaborates with senior and associate members of group on all quality systems.

Participate in all regulatory, third party and customer audits and inspections.

Provide training of other employees on technical, cGMP, safety and administrative aspects of job.

Drives input for continuous improvement activities through participation intra- and interdependently.

Leads consistency in productivity, teamwork and metrics.

Performs other duties as assigned.

Adheres to all applicable procedures, cGMPs, company policies and any other regulatory requirements.

Maak het verschil

You possess the following qualifications, background and abilities:

  • BS in Science or related field
  • At least 3-5 years related work experience in Quality Unit
  • Pharmaceutical industry work experience a plus

Wat bieden wij?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

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