Analytical QA Executive (QA in QC)

Job content

Roles and Responsibilities

• To ensure compliance of training, validation and quality function pertaining to adherence with documents, system and procedure in accordance with the current regulatory expectation
• To review and approve analytical method validation protocols, Report, analytical method development report for routine analysis against the actual raw data, transfer, and stability protocol & summary report.
• To review analytical related activity in change control, deviation, Incident, Out of specifications, CAPA, etc. as and when required.
• To support in investigation of Incident, OOS and OOT to identify the root cause.
• To ensure the analytical raw data, Audit trail of QC instruments and ensuring its adequacy, accuracy on periodic basis.
• Review the raw material and packing material results.
• Review the Bulk (in process) and Finished product results before batch release for GLP compliance.
• Review of all QC related data to ensure the GLP compliance
• To be a part of internal audit team (Self inspection).
• To ensure the completeness of batch manufacturing records / online documentation of logbooks.
• To ensure compliance for document issuance, distribution, retrieval and archival as per the procedure.
• To review and ensure the compliance of retention sample and stability reports as per the procedure.
• Review of risk assessment performed at site.

Thanks & Regards,

Neha Sharma

Asst. Manager - HR