Lead Auditor - Pharma (10-15 yrs)

1. Audits

- Planning of audits (GMP / Verification / transit warehouse).

- Conducting audits (GMP / Verification / transit warehouse)

- Preparation / review of relevant audit reports.

- Maintaining an overview / status of audits.

- Risk assessment of manufacturing sites.

- Contribute to qualification of local manufacturers.

- Developing and training new auditors for pharma and non pharma

- Updation of audit related documents (IPRO, IW, RF, IC) in QMS system

2. Maintenance of address books for suppliers - Approval of V Card in JDE.

- Creation of MP and VMP Card in JDE and its maintenance.

- Manufacturing site UDC creation in JDE.

- Manufacturing site UDC and manufacturing code creation in PIM.

- To maintain V,VMP, MP_OVERVIEW excel sheet for month report.

- Rectification in address book as and when highlighted with supporting documents

3. Product Approval Pharma (as and when required) - Assure quality of pharmaceutical product by assessing dossiers.

- Effective communication with Suppliers and Sourcing team to ensure completion of product approvals within given deadlines.

- Master / Bachelor in Pharmacy education or education in relevant field (chemistry, microbiology, Pharmaceutical Engineering).

- Relevant working experience (more than 5 years)

- Participation in relevant advanced courses/training seminars in past 3 years.

- Experience in performing GMP audits (at least 10 audits) with similar scope