QA Audit & Compliance - Associate/ Sr Associate

OneSource CDMO is looking for a competent resource for QA - Audit & Compliance team. Pls find the JD as below for your reference.

JD for Associate /Sr. Associate:

• Active participation in regulatory/ customer inspections.
• Timely preparation of audit response report and tracking of open actions.
• Review and handling various QMS events in Trackwise such as Deviation, Change Control, and CAPA.
• Coordinating and conducting sites Internal Audit Program as per the schedule.
• Review of USFDA 483s (Observations) and verifying compliance at site level. Identifying the gaps, proposing actions and track them till implementation.
• Maintain data integrity in all activities at site and ensure appropriate and adequate traceability.
• Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance department, in line with Global GMP compliance regulations and industry practices related to Biopharma industry.
• Observing and complying with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Observing and complying with company Standard Operating Procedures (SOPs).
• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the department head, for which training, and/or an explanation has been provided and understood.