QA Operation Specialist (מומחה /ית איכות תפעול)

תיאור:

Unipharm is a fast-growing global pharmaceutical company, developing and manufacturing a wide rang of generic drugs.

We are looking for a QA Operation Specialist to join our QA Operation team.

Responsibilities:

Ensure compliance with regulatory requirements and industry standards.

Write, review, and approve QA documents, including SOPs, specifications, procedures, templates, and forms.

Manage and lead quality events and deviations that occur during the product manufacturing stages.

Performing risk assessments and evaluations

Managing CAPAs, Change Control action items, training execution, and effectiveness checks

Investigate customer complaints related to quality issues

Support internal and external audits

Requirements:

B.Sc. in Life Sciences, Chemistry, Chemical or Biotechnology Engineering – mandatory

1-3 years of experience in a pharmaceutical or medical device company – mandatory

Excellent communication and teamwork skills (must be collaborative and a team player)

Ability to learn quickly, with self-motivation and a strong “can-do” attitude

Proficiency in English and Hebrew (both written and verbal)

Experience in pharmaceutical QA Production or QA Compliance role – an advantage

CQE certification – an advantage