Internal Audits : Perform audits across multiple sites, prepare audit reports and conduct follow-ups to ensure anytime audit readiness of API manufacturing facilities
Mock Audits : Perform cause-based audits with documentation, follow-up for closure of corrective and preventive actions (CAPA) to ensure preparation for external audits
Vendor Audit Support : Perform external manufacturing sites and vendor audits in order to ensure cGMP compliance
Critical System Reviews : To conduct critical system reviews to assess the gaps and to propose the correction plan to harmonization.
Regulatory Compliance Verifications: Verify the regulatory audit responses across sites and their level of implementation. Guide the teams to take appropriate actions.
Technical Requirements: Well versed with cGMP& regulatory guidelines and basic knowledge of API manufacturing.
Key Personal Attributes
- Good communication skills, highly energetic and good influencing ability
- Business and commercial orientation
- Excellent interpersonal skills