Paramjeet Singh

About Paramjeet Singh

Pharmaceutical quality professional with over 21 years of experience in Quality Assurance, Quality Control, and Regulatory Compliance across global markets including the US, EU, MENA, and other. Proven expertise in managing QMS systems, leading regulatory audits (USFDA, TGA, WHO, MHRA, ANVISA), and ensuring compliance across diverse dosage forms such as Solid Oral, Lozenges, MDI, DPI, transdermal patches, injectables, and topical formulations. Adept at vendor audits, SOP harmonization, and technology transfer from R&D to commercial scale. Strong leadership in setting up manufacturing plants and driving quality excellence across multinational operations.CORE COMPETENCIES: Regulatory Audit Management,QMS System, Risk Assessment, Software Proficiency: Trackwise, SAP, LIMS, A,Vendor Qualification & Audit (US & Global), Analytical Method Development & Validation,Team Leadership & Cross-functional Collaboration PROFESSIONAL EXPERIENCEAurolife Pharma LLC, Durham, NC, USA Quality Assurance Engineer | Jun 2022 – Present• Lead Quality Compliance for transdermal patches, MDIs, and topical formulations• Manage internal, regulatory, customer, and vendor audits across US and global sites• Support manufacturing operations and non-conformance investigations• Supported and successfully faced USFDA inspections in August 2022 and March 2024, ensuring compliance.Cipla Ltd, India Senior Manager – Corporate QA & SQA Head | Jan 2015 – Jun 2022• Oversaw QA operations for external manufacturing sites across Australia, Europe, MENA, and China• Led QA for site handling MDI, DPI, tablets, capsules, and lozenges• Directed a team of 49; ensured KPI delivery across CAPA, complaints, deviations, and audit compliance, Successfully led audits including TGA, WHO, INVIMA, and semi-regulatory markets• Spearheaded plant setup and quality oversight for MDI/DPI in MENA regionGlenmark Pharmaceuticals Ltd, Baddi, India Manager – Quality Assurance | May 2010 – Jan 2015• Ensured software compliance to 21 CFR and harmonization of specifications across sites• Managed QMS and QC compliance for multiple dosage forms• Led successful regulatory audits including USFDA, MHRA, ANVISARanbaxy Research Laboratories Ltd, Gurgaon, India Senior Research Scientist – Analytical R&D | Apr 2004 – Apr 2010• Developed and validated analytical methods for APIs and formulations• Supported regulatory filings and specification finalization• Transferred analytical methods from R&D to manufacturing EDUCATION: Master of Pharmacy (Pharmaceutical Chemistry), Panjab University, Chandigarh – 2004

Experience

1. Senior Manager Quality Operation Export Third Party

   Cipla

   Present

Education

• Punjabi University

  Master of pharmacy, Pharmaceutical chemistry

  2002 — 2004