במסגרת התפקיד:
Unipharm is a fast-growing global pharmaceutical company, developing and manufacturing a wide rang of generic drugs.
We are looking for an excellent QA Operation Specialist to join our QA Operation team.
As a QA Operation Specialist, you will support and perform quality activities across the operation department.
In this role you will be responsible for:
Ensuring and maintaining compliance with applicable standards and regulatory requirements
Writing/reviewing team’s documents (SOPs, Specifications, Operating Procedures, Templates and Forms)
Managing and leading quality events and deviations which occurred during the product’s production stages
Conduct cross-functional investigations using Root Cause Analysis (RCA) techniques
Performing risk evaluation according to defects
Managing CAPAs, Change Controls action items and training execution as well as effectiveness checks
Evaluating and investigating customer complaints regarding quality issues
Supporting internal and external audits
דרישות המשרה:
To succeed in this role, you should have the following skills and experience:
B.Sc. Degree: Life science/ Chemistry/ Chemical or Biotechnology Engineering - a must
1-3 years of experience in a pharmaceutical, cell therapy or medical device company- a must
Great communication and influential skills, supportive and service oriented, team player
Eager and capable to learn and be self-taught.
Good English and Hebrew skills (verbal and written).
* Proven experience with pharmaceutical QA role (Production/ Compliance role) - an advantage