Rahiman Shaik
Global Quality Manager at Novartis| Development Quality| 3rd Party Quality Management | Compliance | Quality Risk Assessments | Ex-GSK | Ex-Mylan | Ex-Dr.Reddy\'s |
- Role
- Quality Manager at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rahiman Shaik
Quality Assurance | 14+ Years in Global Pharma | Driving Compliance, Strategy & Excellence:Postgraduate in Chemistry (MSc) with over 14 years of global experience in the regulated pharmaceutical industry, specializing in Quality Assurance, Analytical R&D, and Quality Control. Proven expertise in implementing and managing robust Quality Management Systems (QMS) in alignment with cGMP, ICH, and global regulatory requirements.Skilled in 3rd-party quality oversight, quality risk assessments, lifecycle management, supplier/external engagement, and preparation of critical quality documentation such as Quality Agreements, Site Master Files, Quality Review Boards and Deviation Trending Reports. Adept in authoring, reviewing, and approving global GMP documents, including SOPs, protocols, specifications, and reports.Recognized as a fast learner with high adaptability, I have led and successfully delivered multiple global quality initiatives, driving process improvements and ensuring compliance excellence. I have also played a key role in regulatory and customer audits, contributing to favorable outcomes.I am now seeking a challenging leadership opportunity in Quality Assurance where I can leverage my experience to drive strategic quality initiatives and enhance compliance across global operations.
Experience
Quality Manager
Feb 2024 — Present · Hyderabad, IN
3rd Party Quality Management. Management of external partners & outsourced projects – Managing the contract manufacturers, services & materials supplier for global business units. Managing, establishment and final signature of Quality Agreements & negotiation, quality risk assessment, approval & life cycle management as per company standards as well as Health Authority requirements. Audit management of suppliers, quality alert evaluation and CAPA management. Managing the Health Authority inspections Lead/participate in global/cross-functional key initiatives.
Education
Andhra University
Bachelor's degree, MPC
2005 — 2008
Andhra University
Master's degree, Analytical Chemistry
2009 — 2011
Skills
- Gmp
- Analytical Research & Development
- Pharmaceutics
- Pharmaceutical Industry
- Regulatory Affairs
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