Shraddha Sandesh Suryawanshi
QMS Professional
Koparkhairane
Summary
M.Sc with excellent educational track record and 15+ years’ experience in Pharmaceutical industry, wants to Contribute to Pharmaceutical, Healthcare industry with gained knowledge and experience through effective and quality work performance. Undertake various new initiatives and challenges in new frontiers to exceed expectations towards company goals.
Diligent, result-oriented & accomplished professional; offering over 15+ years of rich & qualitative experience in Analytical Compliance, targeting Leadership Level assignments preferably in Mumbai
Overview
16
16
years of professional experience
1
1
Certification
Work History
Deputy Manager (Analytical Compliance)
Par Formulation
Navi Mumbai
07.2019 - Current
- Ensured self-inspection readiness; supported annual QA self-inspections; prepared compliance reports; assigned and closed CAPAs; and ensured timely resolution of all self-inspection observations.
- Prepared investigation reports for deviations and incidents within the QMS; supported CFTs in change control assessment, impact assessment, and review of SOPs, protocols, and reports in Veeva QualityDocs.
- Evaluated and qualified suppliers, CMOs, and service providers as per cGMP and regulatory requirements; reviewed vendor questionnaires, certifications, audit reports, and QTAs.
- Performed supplier risk classification (critical/major/minor) based on risk and material type; coordinated with Procurement, QC, R&D, Regulatory, and Production during vendor selection and approval.
- Assessed supplier quality systems covering documentation practices, material handling, equipment qualification, validation, and data integrity; identified non-conformances and prepared detailed audit reports.
- Reviewed and approved supplier CAPA plans, verified effectiveness through follow-up audits/remote assessments, and ensured continued GMP/GDP compliance.
- Reviewed supplier-related deviations, change controls, and OOS investigations; maintained the Approved Vendor List (AVL) and ensured vendor status and documentation were current.
- Prepared and maintained vendor audit schedules, audit trails, and vendor files per internal SOPs; identified external testing partners and coordinated CDA/MSA with vendors/third-party labs.
- Planned and executed quarterly reviews of electronic systems (Empower and standalone systems) and ensured timely closure of all review observations.
- Conducted regular ARD lab rounds to ensure GLP, SOP, cGLP, data integrity, and regulatory compliance; reviewed analytical data for accuracy, completeness, and data integrity.
Assistant Manager
CIPLA LTD
Mumbai
07.2009 - 07.2019
- Performed assay, related substances, and other analytical tests of nasal sprays, respules, tablets, and injectables using HPLC.
- Developed analytical methods for chemical testing and characterization of nasal formulations.
- Led the characterization section for respiratory products, including planning, scheduling, and task allocation.
- Coordinated data sharing with statistics teams for PBE studies and supported validation teams during BA/BE studies.
- Trained and qualified junior staff; conducted effective employee skill validation.
- Managed calibration, maintenance, and troubleshooting of HPLC, Malvern Spraytec, Sympatec, ADSA, and other nasal-specific analytical instruments.
- Supported ELN team in creating templates and ensuring accurate digital documentation for nasal studies.
- Executed stability studies for multiple formulations as per regulatory and cGMP requirements.
- Collaborated with cross-functional teams including R&D, Engineering, ELN, and third-party partners to resolve analytical and technical issues.
- Proficient in Chromeleon 6.8, Electronic Lab Notebook (ELN) systems, and Copley analytical software.
- Reviewed analytical data, reports, and documentation for formulation and characterization studies.
- Ensured accurate QC/QA documentation and prepared Certificates of Analysis (COAs) for drug products.
- Updated SOPs, STPs, and specifications in line with revised standards and regulatory requirements.
- Delivered technical and analytical training at Cipla units.
Education
Master of Science - Analytical Chemistry
Mumbai University
Institute Of Science07.2009
Skills
Audits faced
USFDA, LOCAL FDA, VENDOR AUDITS.
Certification
Lean Six Sigma Certification
Timeline
Deputy Manager (Analytical Compliance)
Par Formulation
07.2019 - Current
Lean Six Sigma Certification
10-2018
Assistant Manager
CIPLA LTD
07.2009 - 07.2019
Master of Science - Analytical Chemistry
Mumbai University