Job Description:
QA Operations will support quality oversight in operation activities. maintain quality standards and regulatory requirements.
Responsibilities:
Support the operation and production (clean room, warehouse, supply chain, maintenance, engineering) department activities with all
quality controls and
demands, support with biological testing.
Initiate and implement NCMRs for non-conforming materials/products/process including corrective actions.
Perform Internal audits and take part in external (regulatory, customers) audits.
Analyze and present to management trends and statistics related to QA oversight in operations.
Quality documentation review for ECOs, design control, QMS etc.
Perform batch release as needed.
Other activities as needed.
Direct Manager: QA Manager
Education:
· Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar – an advantage
· CMQ / CQE or similar – an advantage
Job skills:
o 2-5 years of experience in a similar role in a multi-disciplinary company.
o Background in the medical device field – advantage
o Strong knowledge and previous work in clean room
o GMP Knowledge and applicable Quality System Standards
o Keep attention to details.
Computer skills: Full control of all office applications,
SAP knowledge -advantage
Language skills: English- writing and verbal skills
Personality: Excellent communication and leadership skills, organized, motivated
Willingness to work on night shifts
