MAHENDRA DAPLE
Dombivali
Summary
- A strategic leader known for high productivity and efficient task completion. Skilled in team motivation, strategic planning, and conflict resolution, ensuring smooth operations and project success. Excel in communication, adaptability, and problem-solving to lead team effectively towards achieving goals.
- Thorough professional with 19 years of experience in Quality Control section of Pharmaceutical API units approved by various regulatory authorities like USFDA,TGA, EDQM, ANVISA, WHO, etc.
- Expertise in handling sections like Finished Product, Intermediates, In-process, Stability & Non-Routine sections as well as department.
- Expertise in QMS documentation like OOS, Change Control, Deviation, CAPA, Laboratory incidence, OOT, etc. Expertise in finding and handling non-conformances and data integrity issues.
- Support manufacturing and all business requirements. Insightful knowledge of analytical skills/techniques required for Release of FP, API, Intermediates, In-process, stability study materials.
- Expertise in training peers in regular analysis and in special assignments, observing and guiding them to achieve the departmental goals through GLP compliance with cGMP direction.
- Effectively involved in Regulatory audits viz., USFDA, TGA, EDQM, WHO, KFDA, ANVISA and other vendor audits.
Overview
20
20
years of professional experience
Work History
Asst. Manager-QC
Mavelin Trade and Consultancy Pvt. Ltd.
Vashi, Navi Mumbai
08.2023 - Current
- Auditing the facilities (clients) in the view of quality of QC/QA laboratory
- Providing support to the clients for QC laboratory set up in view of regulatory requirements
- Establishment of GLP procedures in the laboratory
- Guiding QC staff of client organization for regular analysis and in day today work
- Involved in establishment of QMS Documentation in QC Laboratory
- Conduct training on cGMP and QA/QC related topics
- To provide support for the compliance of the audit observations and completion of related targets of clients.
Assistant Manager-QC
Centaur Pharmaceuticals Pvt Ltd
Ambernath (W)
02.2023 - 07.2023
- Worked as a section head of Stability section
- Planning and Distribution of stability section work amongst analysts & reviewers
- Stability protocol preparation, schedule preparation, upkeeping stability records
- To initiate and accomplish QCMS Documentation in QC Laboratory
- Approval for stability schedules, stability chamber data, stability analysis & SOP manually and through softwares (LIMS,LMS)
- Ensure the quality system is followed as per SOP in the QC laboratory by continuous monitoring to ensure data integrity in QC laboratory
- To plan and conduct trainings on cGMP, On job and QA/QC related topics
- To initiate, participate in the investigations of non-conformances observed for Stability section.
Associate Manager-QC
ASolution pharmaceuticals Pvt Ltd
Ambernath (East)
06.2018 - 01.2023
- Planning and Distribution of Routine work amongst analysts & reviewers in QC Laboratory
- Ensure the system is followed as per SOP in the QC laboratory by continuous monitoring to ensure data integrity in QC laboratory
- To initiate and accomplish QCMS Documentation in QC Laboratory
- To review reports of Finished Product, Intermediates & In-Process analysis
- To prepare and review master documents like in-process, intermediate, Raw material and finished product specifications & Analytical Work Records
- To review online raw data generated in the laboratory and entries are done in timely manner
- To review audit trail generated on the various instruments in the QC laboratory
- To plan and conduct trainings on cGMP and QA/QC related topics
- To initiate, participate in the investigations of non-conformances observed in the QC laboratory
- To review and approve the HPLC, GC, IR, UV related data in Lab solution software
- To monitor the compliance level of the established Quality system in the laboratory
- Involved in compliance of the audit observations and completion of related CAPA’s
- Involved in internal audits & vendor audits
- To Co-ordinate & co-operate with the other departments, service engineers for smooth functioning of QC Department & goals.
Executive-QC
Indoco Remedies Ltd
Rabale, Navi Mumbai
10.2010 - 06.2018
- Worked as a Reviewer of all the analytical activities carried out in QC Laboratory
- Investigation of Laboratory non-conformances
- Monitoring laboratory activities are in compliance with company policy and cGMP/cGLP regulations
- Monitoring changes implemented to ensure that these are in compliance with the cGMP/cGLP regulations
- Monitoring success of CAPA implemented to reduce number of repeated non-conformance contributed to analytical errors
- Ensuring on-line documentation and timely entries of all operations/activities performed
- Ensuring completion of schedule activity of laboratory
- Responsible to handle Non-Routine activities like Qualification & Maintenance of Standards, Stability Sample analysis and Calibration & Inhouse Preventive Maintenance of QC Instruments/Equipments
- Involved in successful Process validation of 08 products (API) manufactured in plant.
Sr.QC Analyst
D.K.Pharmachem Pvt.Ltd.
Badlapur, Thane
06.2010 - 09.2010
Sr.QC Analyst
Sharon Bio-Medicine Ltd.
Taloja, Raigadh
06.2009 - 06.2010
Sr.QC Officer
Arch Pharmalabs Ltd.
Dombivli (E)
05.2006 - 06.2009
QA/QC Chemist
SUBODH Technologists (Testing Laboratory)
Rabale, Navi Mumbai
08.2004 - 05.2006
Education
M.Sc. (Chemistry) -
Madurai Kamraj University, Madurai through Distant Education
01.2010
B.Sc. (Chemistry) -
B.N.Bandodkar College, Thane (w), Mumbai University
01.2004
Skills
- Cost Reduction
- Employee Scheduling
- Task Delegation
- Product and service knowledge
- Employee Performance Evaluations
- Recruiting and interviewing
- Orientation and training
- Compliance understanding
- Strategic Planning
- Team motivation
- Workload Management
- Audit management
- Regulatory knowledge
- Analytical Skills
Permanentaddress
C-305, Dwarkamai Complex, Nr.Vijay Sales, Behind Rotary Club Garden, Azadegaon, Dombivli (E), 421201.
Noticeperiod
15 days.
Softwareshandled
- Lab Solution software for HPLC, GC,UV,IR.
- SAP ERP system in routine activities of Q.C. dept.
- LIMS & LMS for routine activities of Q.C. dept.
Instrumenthandled
- HPLC– Waters, Shimadzu, Agilent, Dionex.
- GC - Shimadzu, Agilent, Perkin Elmer.
- FTIR- Shimadzu, Perkin Elmer.
- UV Visible Spectrophotometer - Shimadzu
- KF Autotitrator- Veego, Spectralab
- Potentiometer- Lab India
- Polarimeter - Rudolph, Rajadhani, Anton Par.
- Melting Point Apparatus – Lab India, Veego.
- PH Meter – Lab India.
- Weighing Balances – Sartorius, Mettler Toledo.
- TOC Analyzer – Shimadzu.
Personal Information
- Date of Birth: 10/04/83
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
- English
- Hindi
- Marathi
Disclaimer
I do hereby solemnly declare that the above-furnished information is true and correct to the best of my knowledge and belief.
Languages
Marathi
First Language
Accomplishments
- Got a recognition from higher management for successful compliance of USFDA & KFDA audit queries and negotiated with the auditors to their satisfied responses.
- Effectively lead and represented the QC department on behalf of Sr.Manager-QC during his absence in Covid-19 period, for which got promoted to Asst.Manager-QC role by management.
- Had special recognitions many times from management for timely achieving successful release of APIs in business requirements.
Timeline
Asst. Manager-QC
Mavelin Trade and Consultancy Pvt. Ltd.
08.2023 - Current
Assistant Manager-QC
Centaur Pharmaceuticals Pvt Ltd
02.2023 - 07.2023
Associate Manager-QC
ASolution pharmaceuticals Pvt Ltd
06.2018 - 01.2023
Executive-QC
Indoco Remedies Ltd
10.2010 - 06.2018
Sr.QC Analyst
D.K.Pharmachem Pvt.Ltd.
06.2010 - 09.2010
Sr.QC Analyst
Sharon Bio-Medicine Ltd.
06.2009 - 06.2010
Sr.QC Officer
Arch Pharmalabs Ltd.
05.2006 - 06.2009
QA/QC Chemist
SUBODH Technologists (Testing Laboratory)
08.2004 - 05.2006
M.Sc. (Chemistry) -
Madurai Kamraj University, Madurai through Distant Education
B.Sc. (Chemistry) -
B.N.Bandodkar College, Thane (w), Mumbai University
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