Quality Compliance and Excellence

Director/ Principal GxP auditor & GMP Consultant

Advanced MedTech Solutions

HEAD Quality & Regulatory (GM-QA/QC & RA)

Sentiss Pharma Pvt. Ltd.

Sr.Manager Corporate Quality Assurance(sterile Opthalmics &Medical Devices) & CMOs  & Compliance.

Associated with Sentiss Pharma as  Sr. Manager Corporate Quality Assurance. 
Responsible For Vendor Qualifications, CML Audit and compliance , CTL/CRO Audit and compliance, CMO auditing, QMS Systems Improvement , Management Representative For external audits at HO and Research Center, Audit Response,Handling of customer complaints ,supporting plant in regulatory audits, Handling of medical device and CE mark drugs.Management of 6 contract manufacturing locations for tablets, capsules and sterile Opthalamic products etc.

Manager CQA(Sterile Ophthalamic ,Medical Devices  & Injectables), QMS Lead Auditor 

Glenmark Pharmaceuticals

Sterile  and Bulk API production and compliance, QMS,  validation , Qualifications( FAT, SAT, IQ, OQ,PQ) regulatory compliance. Taking care of all types of validation such as process validation, cleaning validation, SHS, DHS, Tunnel validation, Filter validation and  qualifications for sterile and Bulk drug equipment and products.Actively leading teams for investigations and Documents compliance.Taking care of all documents compliance and GMP coordination. sterile  and API Facility Qualifications , Handling Regulatory and customer audits at Facility and compliances.

Manager operation, QMS compliance  & Validations(Sterile and Bulk API Operation Team) 

Ranbaxy

Sterile production of Antibiotics, Qualifications and Validation of sterile facility. Equipment Qualification, SHS and DHS validation, process validation, filter validation and cleaning validation, HVAC validation, Water systems (PW, WFI and Pure steam)  Qualification,  Utility (Nitrogen and compressed air) Qualification, Pre and Post simulation study, Fumigation Validation, Smoke studies, QMS Compliance.

Sr. Executive Sterile operation, Validation , Qualifications and compliance

Orchid Pharma

Sterile Operations, Process simulation,  Media fill, Internal Auditing, Compliance and Validation activities. Hazop studies.Training and GMP coordination.

Executive Operations,QMS compliance  & Validations(Sterile API) 

Wockhardt Ltd.

Responsible for manufacturing of sterile products. Documents compliance and Validation.

Officer  sterile Operation & Validation

Nectar Lifesciences Limited

Responsible for manufacturing of sterile API and documentation.

Sr. Chemist in sterile Operations & Documentations

Modern Diagnostic & Research Centre

Biotechnologist and lab chemist

Director QCE Quality Operations & Principal GxP Auditor. 

Experienced professional for Quality operations, compliance and management of quality, safety & efficacy of APIs,  Injectables, opthalmics, tablets, capsules formulation and medical devices.  

Registered Principal Auditor with IRCA UK and QCI India. 

Six Sigma Master Black Belt certification from Expert Rating, Certified QMS professional  from  Expert Rating. Doctorate in Biotechnology , MBA, PGDRA,PGDCR & CDM, and PGDNBT. 

ISO 9001,14001,45001,17025,22000 & 13485 Certified Lead auditor and EUMDR trained Professional. Experiance in Management of clinical trials.       

SQA, RQM+  & MQA Empanelled Lead IMS & Principal GxP Auditor.

Help in QMS compliance of customer Buisness.

https://qce.co.in 

 Contact No-+91 9106396200

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