Satbir Kaur Email & Phone Number

Hyderabad, Telangana, India

1.The assignment includes oversight of technology transfer of critical launches to support business objectives of more than 60 products across geographies through effective manage-ment of quality systems at third party sites, coordination with affiliates in US/Europe/ Aus-tralia/Rest of the world markets for out licensing and in-licensing products. The role provid-ed a platform for exposure to understanding of various business models and assessment of compliance responsibilities at organization level and business objectives.2. Additional assignment -Management and decision making of quality issues related to critical quality incidents through coordination with other country regional affiliates interaction with senior global leadership, and internal manufacturing, regulatory and supply chain verticals.Management of health authority notifications and determination of field actions based on quality and patient safety risk assessment.

Hyderabad Area, India

The assignment included oversight of site compliance of the quality systems at oral solid dosage form facilities in India region, reporting to the head global quality for OSD. The oversight encompassed the following • Implementation of global policies and procedures and monitoring the effectiveness of the compliance. • Facilitation of site regulatory inspections, response strategies and tracking of the compliance commitments. • Management of critical quality issues related to supplies through other country regional affiliates interaction with senior global leadership, and internal manufacturing and supply chain verticals. • Ensure the critical issues are suitably escalated with-in the organization hierarchy and disposed in accordance with the regulatory expectations. During this tenure, I could accomplish successful remediation of one of OSD sites under USFDA warning letter and management of successful inspections from FDA, MHRA, WHO and HPRA

Sahibzada Ajit Singh Nagar, Punjab, India

An erstwhile Ranbaxy site, where I led the implementation of data governance structure, risk based controls to prevent risk to cGMP data generated across various functions at site. Expertise in handling remediation project in close collaboration with internal and external stakeholders which culminated in success during regulatory inspections and business continuity.

Sahibzada Ajit Singh Nagar, Punjab, India

Led the site quality team at new oral solid dosage form manufacturing unit at Mohali ( SAS Nagar) which is greenfield site Established and mentored a motivated team of professionals to maintain the Quality Systems of the greenfield site that successfully cleared global and simultaneous regulatory inspections (FDA,HC, TGA, EMEA, ANVISA, WHO (Geneva).

Hyderabad

Managed the global regulatory life cycle of over 70 molecules leading a motivated team of regulatory professionals. It was a natural extension of my previous assignment.

Tweleve and a half years experince in quality control and quality assurance of API site.Assuming progressive positions, I managed the quality and compliance program of two API manufacturing sites. Developed expertise in evaluating laboratory and manufacturing quality systems and associated risks and implementation of pragmatic compliance solutions.

Worked as R & D officer and production officer in the improvement projects and troubleshooting in fermentation plant