GMP Compliance Lead

Ensure quality standards for all products and manufacturing activities.

To ensure the GMP compliance throughout the facility.

To organize, educate for and execute activity as per the norms of Quality Assurance objective.

Handling of customer audits.

Releasing or rejecting APIs and Intermediates. Releasing or rejecting intermediates for use outside the control of manufacturing company.

Ensure that the work force is highly motivated and aligned to the Company objectives

Handling of OOS investigation as per the current requirement.

To ensure the compliance of QMS / GMP / GLP

Handling of Regulatory audit and compliance (USFDA / EU / TGA / WHO / Cofepress / KFDA)

Knowledge, Investigation, CAPA ,Handling of Deviation, change control, Incident, lab error

Knowledge of Risk assessments, cleaning validation / ADE / PDE, Preparation of site master file, Quality Manual, VMP handling of Data integrity

Qualification- electronic system / software used in QC and instrument / equipment. i.E familiar with Lims,chromeleon software And other software’s like Electronic system for BPR, DMS,

Handling of Recall.

Compliance report of various audits by outside agencies and customer.

Vendor Audit and approval.

Good knowledge of Analytical Method Validation and Verification.

Review of APQR and Process verification report

Training to all employee as per CGMP.

Candidate from CDMO industry would be preferred.