1. Should have at least 8 years of experience in Pharmaceutical and Consumer product based industry in a Quality Assurance laboratory.
Relevant experience in Pharmaceutical, Personal Care or OTC industry is needed.
2. Sound knowledge of transferring R&D technology to full scale commercial with all necessary regulatory compliances.
3. Responsible for supporting all activities for Quality Assurance within R&D
4. Responsible for Scientific leadership within Quality assurance laboratory including method validation, method suitability troubleshooting, and data transfer from R&D to commercial QA/Qc labs.
5. Review technical problems and procedures within the laboratory and recommend solutions to problems or changes in procedures.
6. Performing technical writing of documents such as SOPS, investigation reports, study protocols, validation and suitability reports and summary reports.
7. Interact with laboratory service vendors to establish service agreements and support investigation or trouble-shooting activities.
8. Assuring compliance with all US(FDA Guidelines, USP, cGMP) and compliance requirements (cGMP and Quality Systems)
9. Must have strong QA/Qc experience under international regulatory environments such as USFDA/EU for pharmaceutical and consumer products.