Radhika Sali

16+ years of experience in Pharma Quality Assurance and QMS domain in API as well as Formulation process. Extensive knowledge of GxP (cGMP, GLP, GCP and GDP) guideline. Proven experience leading or acting as an SME for Veeva Vault QMS deployment.

Deep understanding of Quality Management processes (e.g., CAPA, Change Control, Audit Management, Deviations). Good knowledge of 21 CFR Part 11, CSV, GAMP 5, and Data Integrity requirements. Strong knowledge of industry regulations and compliance frameworks (GxP, 21 CFR Part 11, ISO).

End to end Computer System Validation, Self Inspection, SDLC documentation (Validation plan, URS, DQ, IQ, OQ, PQ, process gap Analysis, traceability matrix, Validation Report). Involvement in client and stake holder communication.

Experience in Change Control form review, Batch Production Records review, Deviation form review. Review of Annual Product Report, Process, Cleaning and Computer System Validation, Master Batch Manufacturing & Packing Records, Self-Inspection Report. Experienced in documentation as per guideline for Quality Audit Records.

Proficient in preparing & revising SOP's Standard Operating Procedure & Validation Plans. Knowledge of Pharmacovigilance on Argus Safety Product Suite 5.1. Knowledgeable with Drug Safety Systems Workflow, Case processing, ICH E2B regulatory guidelines, E2B submission Guidelines.

Extensive knowledge of clinical and quality systems best practices including FDA cGxP, EMEA, ICH etc. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Establishing quality goals, perform quality metrics trending for problem solving, system improvements to meet these target levels of quality.

Lead Executive - Apotex Research Pvt. Ltd.

(2018-04 - 2024-09)

Corporate Quality Assurance – APQR, CSV and Veeva Vault

• Managing document lifecycle activities Vault Quality suite (Vault QMS, Vault Quality Docs, Vault Training).
• Configure and support workflows for deviations, CAPAs, change control, complaints, and audits.
• Create and manage controlled documents, SOPs, training assignments, and periodic reviews.
• Experience with system integration and IT infrastructure
• Manage change requests, configuration, and enhancements in Vault application
• Working experience on Val Genesis, Jira, API and QTest tools.
• Configured and optimized MLR and Medical/Scientific review workflows in Veeva Vault PromoMats, including lifecycle management, approvals, reviewer routing, annotations, compliance validation, and workflow automation.
• Stakeholder management and good executor with required communication.
• Review Annual Product Quality Reviews (APQRs) for Canada, US, EU, RoW market and Third-Party Manufacturer (External Manufacturing Quality/ contract Manufacturer).
• Summarize and trend analytical data from LIMS or other acceptable systems.
• Review of all Quality Management system documents.
• Co-ordinate with stakeholders (Canada) and Project Leader(s) – QA Product Review in timely manner and escalate the issues.
• Develop and mentor the APQR compilers to meet the compliance levels.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Professional experience in Computer System Validation.
• Leads to effort to manage and maintains Validation of the GxP computerized system.
• Create and review Validation Plan, Validation Report and Validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
• Ensure GxP Computerized Systems are validated as per GAMP 5, US FDA 21 CFR Part 11 and Data Integrity requirements.
• Knowledge sharing with different topics with team members.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Establishing quality goals, perform quality metrics trending for problem solving, system improvements to meet these target levels of quality.

Executive - Teva Pharmaceuticals Ltd.

(2015-04 - 2018-03)

Corporate Quality Assurance – CSV and Annual Report Quality Review

• Create and review Validation Plan, Validation Report and Validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
• Ensure GxP Computerized Systems are validated as per GAMP 5, US FDA 21 CFR Part 11requirements.
• Review, evaluation and compilation of APQRs for EU and Third-Party Manufacturer (CMOs).
• Compiling quality data, performing trend analysis, tracking and reporting deviation trends in APQR's and ensure accuracy and completeness of data.
• Handling and retrieving trends and data from Track-wise Harmony, Qualiteam, Global Insight, RADAR, SAP BW and SAP N20 Production.
• Evaluate reviews, recommend actions and professionally communicate to sites so as to continually improve quality of products.
• Carrying out any task delegated by Management which contribute to overall running of the department e.g. assistance with different ongoing projects.
• Managing the telecommunications with EU stakeholders, preparing agenda and minutes of meeting.
• Managing and evaluating of Quality management system activities.
• Preparation and evaluation of weekly and monthly report, matrix as per the schedule.

Executive Quality Assurance - Orex Pharma Pvt. Ltd

(2012-09 - 2015-04)

All QA documents review

• Preparation and review of Master Batch Manufacturing Records and batch records.
• Master protocol preparation of Process validation, Cleaning Validation & checking of Process Validation reports.
• Preparation of Validation Master plan, All departmental manual.
• Release or reject raw materials and intermediate products. Release or reject packaging and labeling materials and the final containers in which drugs are to be placed.
• To monitor the manufacturing activities by in-process quality checks and to ensure that the manufacturing activities are carried out as per the laid down Systems and procedures
• Review of all Quality Management system documents.
• Co-ordinate with stakeholders (Canada) and Project Leader(s) – QA Product Review in timely manner and escalate the issues.
• Develop and mentor the APQR compilers to meet the compliance levels.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Professional experience in Computer System Validation.
• Leads to effort to manage and maintains Validation of the GxP computerized system.
• Create and review Validation Plan, Validation Report and Validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
• Ensure GxP Computerized Systems are validated as per GAMP 5, US FDA 21 CFR Part 11 and Data Integrity requirements.
• Knowledge sharing with different topics with team members.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Establishing quality goals, perform quality metrics trending for problem solving, system improvements to meet these target levels of quality.

System Engineer - Tata Consultancy Services

(2011-11 - 2012-01)

Pharmacovigilance - Oracle Argus Safety

• Booking Cases: Review of the process of creating new cases, including a review of the Case ID Generation and Duplicate Check functions.
• Managing Cases: Review of case management features, including case workflow basics.
• Basic Case Query: Review of the basics of using the Query Module to identify cases of interest.

Sr. Quality Assurance Officer - Lupin Ltd., Tarapur

(2011-02 - 2011-05)

• Change Control form, deviation reports, Corrective Action & Preventive Action (CAPA) form review.
• Annual Product report preparation & review Active Pharmaceutical Ingredient Product Specific APR.
• Preparation of Master Batch Production Records.
• To fulfill Regulatory requirements & reply to all requirements.
• Measurement of Risk Assessment & Corrective & preventive Action.
• Material to material transfer, Create UD (Usage Decision) of the product through SAP system.

Quality Assurance Officer - Okasa Pharma, Satara

(2007-12 - 2010-01)

• Change Control form and impact assessment review.
• Self-Inspection reports review, Preparation of Self Inspection schedule & checklist.
• Annual Product report preparation & review for General Tablet, Cephalosporin Tablet, Capsule, dry syrup, Injection & Veterinary dry powder & Product Specific APR. Collect & Organize all production & Quality Control data associated with the annual product review & provide the summary of results.
• Deviation reports review, Corrective Action & Preventive Action (CAPA) form review.
• Process validation and Qualification Impact Assessment, Validation reports review, Summary for validation reports
• Review of Equipment qualification, computerized system validation.
• Review of Batch Manufacturing Record & Batch Packaging Record.
• Well aware of Pharmacopoeia, GMP, cGMP, FDA, ICH, WHO, MCC, MHRH Guidelines and APVMA regulations.
• All Quality Assurance documents review.
• Preparation of Audit Compliance & fulfill the requirement.
• Preparation of Annual Product Reports.
• Preparation of Drug Master File in CTD format and Site Master File
• Change Control form review.
• Deviation log maintenance, deviation reports review, Corrective Action & Preventive Action (CAPA) form review, deviation Excel log & co-ordination to all departments related to deviation form.
• Self-Inspection reports issuance, review, log maintenance, Corrective & preventive action prepared, collecting and reviewing data for monthly statistics of self-audit report, GMP.
• Audit Exposure for WHO & FP CMO Pharma companies.

Master in Business Administration - Total Quality Management, Clinical Research Management - Indian Institute of Business Management & Studies (2012 - 2012)

Bachelor of Pharmacy - Bharati Vidyapeeth's Collage of Pharmacy (2007 - 2007)

Diploma in Quality Control & Quality Assurance Management - D.P.Q.C.Q.A.M.

• Institute of Pharmaceutical Education & Research (Pune) Pvt. Ltd.

Professional Diploma in Clinical Research - PDCR - Catalyst Clinical Services Pvt. Ltd. Delhi (2006 - 2007)