Raghvendra Singh

About Raghvendra Singh

In all this years of my QA experience in pharma industry, learned a lot and was always…

Experience

1. Senior Quality Assurance Specialist

   Zentiva

   Aug 2022 — Present · Ankleswar, IN

   Responsible for management of dedicated product portfolio which includes: Complaint Management:• To provide support to the investigation into the complaint carried out by the team in the manufacturing plant, to ensure that the complaint sample is provided to the manufacturing site on time and availability of any other material needed by the CMO for further investigation in conjunction with market affiliates.• To provide support related to any additional information needed by the manufacturing site [CMO] to carry out the investigation.• To ensure any critical issues get escalated at an appropriate escalation level. To ensure the required investigation is completed and corrective action is implemented on time; track the timely closure of complaints. And to report Complaint KPIs. Deviation & CAPA Management:• To track and monitor all the major & critical deviations related to CMO functions for timely closure.• Escalate critical deviations and any overdue situations in deviation closure to Deviation Review Board.• To report Deviation and CAPA KPIs.• To track the progress of all CAPAs generated at CMO functions for timely closure.• Escalate any exceptions in CAPA Management in Deviation Review Board. Change Control management:• To assess new change proposals, perform impact assessment, evaluate the justification and identify the actions relevant to the change proposal as per the defined change matrix. Product Quality Review Process:• Tracking of CMOs PQR & identified review actions for completion.• Review of PQR and its summarized evaluation report.• Follow up with CMOs for compliance of observed issue during PQR review. Other Responsibilities:• To identify and escalate the risks foreseen relevant to the assigned profile and mitigate it.• Quality agreement creation for the Product launches/transfers with associated CMO’s as per the defined template.• Audit plan preparation and to perform the external audits in line with valid audit plan of CMOs.

Education

• Dept. of Pharmacy, B.U., Bhopal

  B.Pharm.

  2005 — 2009

• Institute of Pharmacy, Nirma University

  M.Pharm.

  2009 — 2011