Quality Assurance
Quality Assurance
1
Applications
Ahmedabad
Full-Time
Mid-Level: 2 to 4 years
₹ 2L - ₹ 4L (Per Year)
Posted on Mar 25 2025
About the Job
Skills
Deviation Management
Goods Clinical Practice
GCP
SOPs
Vendor Qualification
CAPA Management
Responsibilities:
- Controlling & Distribution of Documents
- Pharmacovigilance Quality System Oversight & Compliance Monitoring
- Internal Audits Management
- Handling of TRackQS - Learning Management system software with respect to QMS activity and training deliverables
- Deviation management
- Handling of Client Audit/ Visit, Regulatory Inspections & Addressing Vendor Assessment Questioners
- Conducting or Assisting in QMS Audits, Site Qualification Audits, For Cause Audits and Pre-Inspection Audits for GxP functions of Pharmazone
- Vendor Qualification
- Review of Project Data prior to Archival
- SOP Preparation, Upgradation & Management
- CAPA Management
- Oversight of archival activities and management of archive
About the company
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Inte ...Show More
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patients lives through unique Commit-Collaborate-Carry Model. As a Regulatory Specialist, we assist our clients with solutions like Regulatory Intelligence & Strategy, Medical Writing, Submission & Publishing, Artwork, Labelling, translation, Health Authority interactions, and all post-approval requirements including an end to end Pharmacovigilance services like case management, Aggregate Reports, Signal Detection, MICC, etc. Our objective is to help large, medium & small-size life science companies in efficient execution & compliance of their drug development plans and Post-Approval Requirements for regulated markets and the developing world. Global Regulatory Landscape is dynamic and our compliance services (GXP) play a vital role for clients. Being a trendsetter in GCP Auditing & Consulting, Pharmazone has successfully carried out 2000+ projects for Clinical Monitoring (Bioequivalence, Late Phase), Study Design, Audits, CRO setup & Up-gradation & Programme Management. Our GMP Solutions include Audits, Report Library, Quality Consulting, USFDA/EMA/PICS/WHO accreditation Support, CSV & Engineering Services including Plant Setup & Upgradation. Though Client's trust is our biggest recognition, our hard work-filled journey has brought us various awards like "Best HealthCare Brand" by CMO Asia -ABP News, Top 10 Clinical Research Provider by Silicon India. "Value Creation by Right solutions is Working Mantra at Pharmazone. The expert team at our global locations (INDIA, USA, CANADA and CHINA) have served 300+ Clients to satisfaction and we look forward to serving you! ...Show Less
Industry
Pharmaceutical Manufactur...
Company Size
51-200 Employees
Headquarter
Ahmedabad
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