Antriksh Mohan Vyas
Manager- Quality Assurance
- Role
- Quality Assurance Manager at Piramal Pharma Ltd
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About Antriksh Mohan Vyas
Quality Assurance (QA) professional, Proven expertise in leading vendor site audits as Lead Auditor, including audit planning, execution, audit report preparation, compliance review, and follow-up of corrective actions. Specialized in nitrosamine impurity risk assessment, including preparation and review of nitrosamine risk assessment reports, identification of qualified laboratories for nitrosamine testing, and implementation of effective mitigation strategies to control nitrosamine impurities in drug products. Experienced in market complaint handling, including investigation, preparation and review of investigation reports, actual root cause identification, and recommendation and implementation of effective CAPA in line with quality system requirements.Strong hands-on experience in deviation management, change control, and development of alternate vendors, including cost optimization activities for existing products without compromising quality or compliance. Well-versed in equivalency assessments, regulatory audit handling, and management of war rooms during regulatory inspections and critical quality issues.Adept at qualification of external testing laboratories, management of Quality Technical Agreements (QTAs) with vendors, customers, and third-party service providers, ensuring clear quality responsibilities and regulatory alignment. Committed to maintaining product quality, patient safety, and continuous improvement across the pharmaceutical quality lifecycle.
Experience
Quality Assurance Manager
May 2024 — Present · IN
Education
Smriti College of Pharmaceutical Education (SCOPE)
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
2009 — 2013
Smriti College of Pharmaceutical Education (SCOPE)
Bachelor of Pharmacy, Pharmacy
Kendriya Vidyalaya
10, Biology, General
2005 — 2008
Smriti Collage Of Pharmaceutical Education.
Bachelor's Degree, Pharmaceutical Sciences
2009 — 2013
Skills
- Technology Transfer
- Anda
- Research
- Hplc
- Validation
- Laboratory
- Pharmaceutical Industry
- Sop
- Fda
- R&D
- Cosmetics
- Glp
- Tablets
- Life Sciences
- Pharmaceutics
- Syrups
- Microsoft Office
- Biotechnology
- Formulation
- Pharmacovigilance
- Gmp
- Capsules
- Regulatory Affairs
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