Ramani Krupa

Looking for challenging opportunities to be a part of an esteemed organization & contribute my knowledge to the success of the organization.

• Corporate QA
• Quality management system

Ø Current: -

· Responsible for submitting documents to regulatory authorities for filing in multiple countries.

· Prepare and review master records for “SMF.”

· Approval of Artwork.

· Handling of vendor approval process.

· Data compilation, Preparation, and review of Annual Product Quality Review (APQR).

· Preparation of CPV and CQA of various product.

· Issuance and Handling of deviation.

· Issuance and Handling of change control.

· Issuance and Handling of OOS document.

· Preparation and review of SOPs.

· Issuance of various document like standard format, Logbook, Protocol etc.

· Overall responsibility for overseeing documentation activities, including review and approval of SOPs,

· Participate in internal audits, customer audits and regulatory audits and verify compliance/measures taken.

· Responsible for preparing regulatory compliance reports and other client audits.

· Participate in evaluating and assessing the capacity of raw material and packaging suppliers.

· Responsible for coordination with other departments.

Ø Previous: -

· Issuance and Handling of Change Control.

· Issuance and Handling of Deviation.

· Data compilation, Preparation, and review of Annual Product Quality Review (APQR).

· Handling of Stability study- Review of protocol and report of stability study, evaluation of the result and trending of stability data.

· Plan, Execute, Handling, follow up and compliance of self-inspection.

· Preparation and review of SOPs.

· Final Review of Batch Manufacturing Record & Batch Packing Record.

• Issuance of Batch Manufacturing Record, Batch Packing Record & standard Format.
• Issuance and retrieval of SOPs

· Performing of IPQA activity as per cGMP practice & All other work related to QA.

· During audit represent documents as per requirement of auditors.

Regulatory audit: PICS, WHO, MSF (France, MCAZ(Zimbabwe), NDA (Uganda), MOH (Kenya), MOH (Moldova), MOH (Sudan), INVIMA (Columbia), TMDA (Tanzania).

• Date of Birth: 05/18/91
• Gender: Female
• Nationality: Indian
• Marital Status: Single

English, Gujarati, Hindi

I hereby declare that all the information furnished in this application is complete and correct to best of my knowledge and belief.