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QA Assistant
2 weeks ago
Assist in the implementation and maintenance of the quality management systems in accordance with relevant quality standards and regulatory requirements (cGMP, 21 CFR, EU MDD, ISO 13485 and ISO 9001 as applicable).
Assist in updating documents required for meeting the development of QA strategies, recommendations for continual improvement, quality planning for each product range.
Provide data such as acceptable claims, wordings, performance data and other information to market the products
Provide material/information required by Regulatory Authority for import, reimbursement and product registration.
Support in company vigilance system including product recall activity.
Assist in documenting approved starting raw and packaging materials, bulk solutions and finished products that meet requirements.
Establishment verification and implementation of all company procedures to comply with cGMP and ISO requirement.
Assist in employee cGMP training such as employee orientation, quality awareness and job training.
Verify and make changes to label/artwork (liaise with vendors on changes and updates when required)
**Requirements**:
Diploma/Degree in life science
Proficient in MS Office
**Reg No**: R1653797
**EA License No**: 20C0426
(Elitez & Associates)
Diploma/ Advance Diploma
Minimum of 1 year(s) experience needed for this position