Gurpal Singh

Create center of excellence and deliver QA services to Global Quality functions for processes like complaints management, change control, supplier quality management, Auditing, APQR, Product release, Stability studies, Technical training and Artwork. Gain efficiencies via continuous improvement, automation and implementing data & digital solutions. Position Level: Director; Team Size: >100; Financial Impact: > 10 M$

Centralization and digitization of QA operations

Provide Quality oversight to all the third party manufacturing sites of Merck in India doing custom manufacturing of drug substance and drug intermediates for global pharmaceutical prescription products, including investigation and management of all quality related issues and escalations. Act as QA SME within supplier relationship team for due diligence audits, selection of new CMOs, technology transfer projects and regulatory inspections.

Product release, review and approval of complaint, deviation, process change control, validation & qualification reports. Perform self-audits and facilitate site quality performance review.

Analytical testing (GC/HPLC), stability studies, sample management, laboratory equipment calibration and qualification, analytical method validation & transfer and analytical data review.

Chemistry

Operations Research

Chemistry