Sanjaya Panigrahy
Quality Compliance Manager @PQE Group
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WORK HISTORY
Quality Compliance Manager @PQE Group
Hyderabad, IN
Perform various onsite and virtual audits (GxP, GAP, and due diligence) for non-sterile and sterile API/FDF and PM sites on behalf of US and EU-based clients and ensure timelines meet established expectations.•Assist the third-party audit team in preparation of the annual audit schedule, using risk-based approaches for auditor assignment.• Lead and coordinate with Clients and impacted Site Quality leads on critical audit findings and/or audit refusals. • Supporting clients remotely for QMS investigations and review of technical qualification (CSV and Equipment) documents.
EDUCATION
Roland Institute of Pharmaceutical Sciences (RIPS), Berhampur
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences, A
Jamia Hamdard
PG Diploma, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, A
Biju Patnaik University of Technology, Odisha
Master's degree, Pharmacy, O Grade
ABOUT SANJAYA PANIGRAHY
An IRCA/CQI Certified ISO 9001:2015 Lead Auditor, with 15 years of successful track record in Pharma Quality function. Sound knowledge of cGMP & Regulatory requirements. Expertise in QMS, Audit and Compliance, IPQA, and Vendor Management(Audited around 50+ vendors). Have greenfield experience for OSD block. Worked in both roles, i.e. as a ‘People Manager’ and as an ‘Individual Contributor’. Possesses a high degree of personal and professional ethics. Certifications - Certified ISO 9001:2015 Internal QMS Auditor - SR Choda Institute - PG Diploma in Regulatory Affairs - Jamia Hamdard- Advance Diploma in QA Management - IPER, Pune.
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