Pradip Mahale
Ahmedabad
Summary
Proactive and multi-skilled professional with approx.18 years of experience in, Pharma API new project handling, various formulation QA & QC documentation, Vendor qualification of various pharmaceutical manufacturing organizations with the product category of API, tablet, capsule & liquids manufacturing facilities.
Overview
17
17
years of professional experience
1
1
Language
Work History
Head QA / Manager
Loxim Industries Ltd
03.2025 - Current
- Handling of New greenfield API manufacturing project.
- Handling the FDA approvals for plant (layout approval, State FDA approval, PESO, FIRE & IBR approvals) along with consultant.
- Technical Oversight: Review engineering plans (Production/QA/QC), interpret technical diagrams, and ensure compliance with cGMP standards.
- Closely with project managers to develop work plans, timelines, User requirement, FAT & SAT, IQ, OQ & PQ preparation & completion.
- Review and approval of qualification documents / Protocols & reports (FAT/IQ/OQ/PQ) for equipment’s & utilities.
- Preparation & review of Validation protocol and performing its Validation as per its protocol
- Responsible for Qualification & validation activities to be carried out at site.
- Review and approval of raw materials / finished API samples & its documents (COA / Specification/ MOA/test reports) for R&D.
- Prepare & conduct cGMP trainings to all employees at sites / corporate office employees.
- Ensuring API plant project activities meet regulatory requirements and quality standards.
- Regulatory approval pathway decision for the Saykha (Bharuch) upcoming API site.
- Incident and Deviation handling & CAPA evaluation.
- Evaluating suppliers to ensure they provide raw materials and equipment’s / its components that meet quality standards (GMP).
- Day to day activities monitoring in R&D / ADL lab meeting to cGMP. (handling change control, Deviations, incidents / batch records / spec preparation, review and approval, conduct internal audits, GDP etc.)
- Loxim Industries Ltd. pharma API manufacturing site at Saykha (Bharuch) & hired as QA head.
Manager- Corporate Quality Assurance
Intas pharmaceuticals Ltd.
08.2020 - 03.2025
- Perform Audit of External API, Intermediates, API starting materials, Excipients (Raw Materials), Contract manufacturing sites- (LL) (API Formulation), consumable, service providers & Packing material manufacturers across the globe.
- Handling vendor team size of 6 persons.
- To ensure that the vendor (for Raw Material, Packaging Material, Excipients and Service Providers) of the Intas group of companies are qualified includes carrying and/or supervision related activities.
- To prepare and submit Audit Report to the Vendor and to check the compliance Report.
- Monitoring daily / monthly quality activities of the team to support on time closure of complaints, deviations and change controls.
- Handling of Customer & regulatory audits at Intas pharma (present vendor part)
- Review and approval of change control, market complaints, deviations, technical agreements, quality risk assessment & all day to day vendor related activities.
- Leading quality investigations (OOS) at Intas site & Identifying the root cause & its implementation of CAPA.
- Handling, review and finalization of Quality agreements.
- To assist DGM-CQA & V.P in continuous systems updation in compliance of quality systems e.g. change controls, deviations, incidences, customer complaints etc.
- To conduct Quality Audits & taking part in Internal Audit at different locations of Intas. Pharmaceutical.
- Review and Approval of Standard Operating Procedures and Corporate guidelines.
- Training to Employees on Corporate Quality Assurance procedures / on GMP guidelines.
- Intas pharmaceuticals Ltd. - Ahmedabad is well known Indian multinational pharmaceutical company caters all type of pharmaceutical medicine to all over world.
Assistant Manager – Vendor Development
ACG Associated Capsule Pvt Ltd.
02.2018 - 08.2020
- Alternate vendor development- New supplier Identification of monopoly/single vendors across all sites & assessment as per GMP norms and company policies.
- Handling of technical issues for internal & outsourced materials by visits, telecoms & meetings where ever required
- Supporting for Resolving Technical Issues and Closing material complaints & rejections for ACG plants. Root cause analysis & its closing.
- Identify improvement areas where necessary areas, prepare solutions on the identified gaps & working with supplier to mitigate the gap.
- Preparation of annual audit schedule. Visiting / Auditing of Excipients & Packing materials manufacturers.
- Commercial Negotiation with suppliers & handling of Quality agreements.
- Negotiate with external vendors, Finalize till deliveries.
- Support R&D/QC/RA/QA in arranging the required VQ documents from vendor. Specification finalization & method transfer to bridging the gap between manufacturer and vendor end.
- Monthly Supplier rating monitoring.
- Implement vendor processes and methods to add / empanel vendors. Supplier process up gradation & production Expedition for on time deliveries.
- Completion of Vendor qualification & vendor Audits as per GQA procedure.
- Risk assessment (as per FMEA) and continuing vendor monitoring is being accomplished.
- Supplier sustainability assessment.
- Arranging & review of documents from vendors & helps to Regulatory dept for DMF/dossier fillings.
- Weekly conducting meeting with R&D, QA/RA for closure of all open issues.
- ACG Associated Capsule Pvt Ltd., Kandivali Mumbai- World second largest manufacturer of hard Gelatin & HPMC capsules manufacturer and supplier & caters to all over the world.
Assistant Manager - Vendor Quality (GQM)
Dr. Reddys laboratories ltd.
06.2014 - 02.2018
- Planning, Preparation & Perform Audit of External API, Intermediates, API starting materials, Excipients (Raw Materials), Contract manufacturing sites- (SBP & LL) & Packing material manufacturers.
- Preparation of Audit report in SAP & rating the vendor on the basis of audit findings.
- Vendor audit CAPA follow up for closure as per the committed time lines, Check the adequacy of the audit CAPA, review and upload in SAP.
- Review and approve vendor audit reports and response and ensure quality of reports and responses.
- Review and approving change management proposals & ensuring that all QMS requirements are in place while approving the changes.
- To Support and ensure the compliance of regulatory and external customer audits held at CTOs sites with respect to VQ related part.
- Vendor documents review & updation.
- Support the needy vendors to upgrade the quality systems (GMP/quality) improvement initiative at vendor sites. Handling of Compliance & follow-up for CAPA for all External vendors.
- Prepare and submit MIS reports / Presentations highlighting incidents of failures, deviations, changes, complaints etc. to senior management.
- Coordinating with SCM & CTO to track the RM rejections, Check adequate root cause and CAPA received from the vendor. Preparation of Annual Material rejection analysis.
- Work with the sourcing team/SCM on identification and on boarding of new vendor's qualification as part of AVD/PACE initiative.
- Coordinate and timely support with SCM & RA teams for all regulatory requirements as part of filings and deficiency wrt VQ.
- Physical support to regulatory audits at internal sites & at external supplier/ Manufacturer.
- Coordinate to Perform periodical review and evaluation of vendors as per SOP.
- CAPA remediation support to various CTO and FTO units at Dr. Reddys lab.
- Development & conduct training to External manufacturer.
- Preparation of Annual Material rejection analysis. Tracking and review of material rejection across all the Dr. Reddy’s CTO sites.
Management Staff, CQA (Vendor Quality)
CIPLA LTD
07.2010 - 06.2014
- Planning, Preparing, Conducting and Reporting of GMP and Quality system Audits for API, Excipients, Chemicals & Packaging Material Vendors.
- Writing Audit Reports in-line with the Corporate Reporting Templates.
- Monitoring that Corrective and Preventive Actions related to the audit findings (Major/Minor/Critical) are implemented appropriately and as per schedule
- Review of vendor audit related technical documents such as COA, OVI statements, Stability trends, Audit reports etc.
- Review and Approval of Manufacturing Sites on the basis of qualifying Documents.
- Management of Documents ( TSE/ BSE, VAR, OVI, COA, GMP agreement etc )
- Support to various Cipla unit to comply with documentation related requirement for Vendor Management.
- Preparation of Global & local audit schedule
- Handling of vendor management system software
QA Officer
Ajanta Pharma Ltd.
11.2009 - 06.2010
- Preparation of stability Protocol & Monitoring of Stability Program.
- Review & Handling Change control, Deviation Control & Out of Specification.
- Review, Distribution, Approval & Control of Specification, MFR, MPR, BMR & STP.
- Review & preparation of Site master file, quality Manual & VMP (Validation Master Plan)
- Conducting Internal Audits in research centre.
- Preparation & Monitoring of internal & external calibration schedules.
QA Chemist
Aurochem Pharmaceutical (I) Pvt. Ltd.
07.2008 - 11.2009
- IPQA
- Issue of MFR & BMR to different manufacturing sites to Regulatory department.
- GMP monitoring: Monitoring day-to-day activities in Research centre.
- Knowledge of LIMS.
- Qualification of Equipment
- Preparation of BMR, BPR, SOP, ECR, Analytical Protocol & Finish Product Specification.
- Knowledge & Handling of “Fox V-PRO” (Pharma Software).
- Batch Scheduling, RM & PM Requisition.
- Issuance of BMR, BPR SOP, ECR & Other Documents.
- In process checking from dispensing to dispatch.
- Monitoring the cGMP in Company.
- Handling of OOS, Deviation control & Change Control.
- Good knowledge of Validation & Qualification.
- Preparation of Training Schedule, Self inspection & Internal Audit.
- Review of BMR, BPR, ECR, SOP, Log Books.
- Operation & Calibration of DT Apparatus, Friability, Balance, IR Moisture, Hardness Tester, PH Meter
- To face the Audit. (WHO, USFDA, MHRA, NAFDAC, NDA, TGA)
Education
M.Sc. - Microbiology
N.M.U Jalgaon
Jalgaon, India01.2008
B.Sc. - Microbiology
N.M.U Jalgaon
Jalgaon, India01.2006
H.S.C. - undefined
Nasik Board
Nasik, India01.2003
S.S.C - undefined
Nasik Board
Nasik, India01.2001
Skills
Proficient in Microsoft Office, Excel, DTP, Email Systems, and Windows Programmes
Interests
Reading Newspaper, Searching Wikipedia & Literatures
Training Detail
- ISO 9001 : 2015 certified as QMS Lead auditor - ACG Associated Capsules Pvt. Ltd - CQI & IRCA
- Undergone training on “ICH Q7” - Cipla Ltd - Mr. R. Raghunandan (Pharma consultant).
- Undergone training on “External & Internal Audit Management. - Cipla Ltd - Mr. R. Raghunandan (Pharma consultant).
- Undergone training on “Review of Data Integrity”. - Cipla Ltd - Mr. Derek Smith
- Undergone training on ICH Q7 & Quality risk management (ICH Q9) - Dr. Reddys laboratories Ltd. - Mr. Tonny Mourice (QP)
- GMP Auditor Qualification "Conducting & Facing GMP Audits Effectively" - Dr. Reddys laboratories Ltd. - Mr. Mahesh Kulkarni
Disclaimer
I hereby declare that the information mentioned above is true to the best of my knowledge.
Timeline
Head QA / Manager
Loxim Industries Ltd
03.2025 - Current
Manager- Corporate Quality Assurance
Intas pharmaceuticals Ltd.
08.2020 - 03.2025
Assistant Manager – Vendor Development
ACG Associated Capsule Pvt Ltd.
02.2018 - 08.2020
Assistant Manager - Vendor Quality (GQM)
Dr. Reddys laboratories ltd.
06.2014 - 02.2018
Management Staff, CQA (Vendor Quality)
CIPLA LTD
07.2010 - 06.2014
QA Officer
Ajanta Pharma Ltd.
11.2009 - 06.2010
QA Chemist
Aurochem Pharmaceutical (I) Pvt. Ltd.
07.2008 - 11.2009
B.Sc. - Microbiology
N.M.U Jalgaon
H.S.C. - undefined
Nasik Board
S.S.C - undefined
Nasik Board
M.Sc. - Microbiology
N.M.U Jalgaon