The QA DS specialist will work as a QA contact person responsible for DS QA oversight as an area of responsibility.
Work as a QA contact person with Drug Substance as an area of responsibility.
• Provide general QA expertise and support for DS
• Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
• Support and approve Change Control records
• Participate in CAPAs resolution of inspection findings.
• QA review and approval of master batch records.
• Review of batch records and associated documents from DS before a formal release to the next manufacturing step
• QA review and approval of records and reports related to area of responsibility.
• QA approver for any quality records related to DS processes
Qualifications and Level of Experience
• A university degree in related discipline, e.g pharmacy, biology, chemistry
• Experience with working in a QA environmant and adhering to GMP standards
• Knowledge of DS manufacturing processes for biosimilars is preferred