Nikunj Patel

Ø Audit Compliance

Management of External audit/inspection:

• Co-ordination with Regulatory Authorities and Clients/ customers for planning of audit at manufacturing site.
• Arrangements for audit like audit team, war room & audit documents to ensure timely availability of documents to auditor.
• Preparation of audit compliance report.
• Tracking of open CAPA, follow-up and CAPA effectiveness check.

Management of Internal audit/self-inspection:

• Scheduling, Conducting & Execution of Internal audits.
• Review of internal audit reports and compliance reports.

Ø QA Co-ordinator for Customer

• Co-ordination with clients/customers for review and approval of various GMP documents.
• Compilation and Submission of documents for new product dossier/variation approval.
• Handling of any query arises for the product, process or document throughout the product life cycle (i.e. during product registration as well as post-approval during routine commercialization).

Ø Management of Quality/Technical agreement with Clients/customers

• Review and finalization of Quality/Technical agreement with Clients/customer.
• Co-ordination with cross-functional team to ensure implementation of client specific requirements as per Quality/Technical agreement.

Ø Management of Document control cell

• Monitoring of document control (preparation, issuance, retrieval, destruction); both manual and electronic documents.
• Assurance of document traceability and appropriate arrangement in document cell throughout its life cycle.

Ø Management of Retain sample: Monitoring of retain sample management (receipt, arrangement, periodic verification, issuance and destruction), throughout its life cycle.

Ø Review of Quality Management System

• Change control,
• Quality Risk Management,
• Deviation & Market complaint investigation,
• CAPA and its effectiveness

Ø Management of Hold time study validation: Preparation of Hold time study protocol and report, Sampling of in-process materials and bulk product for hold time study.

Ø Review of Executed Batch Manufacturing and Packing Record.

Ø Preparation of Product Quality Review (PQR).

Ø Submission of executed batch documents to client and handling queries raised by client.

Ø Preparation of Master Batch Manufacturing and Packing record.

Ø In process quality check-up of Tablet & Capsule.

Ø Sampling of in process and finished products.

Ø Line clearance before start of manufacturing/packaging process.

Ø Conducting lectures and practical concerning various pharmacy subjects like Human Anatomy & Physiology, Pathophysiology, Bio-chemistry, Pharmacology, and Clinical Pharmacy.