Manish Joshi
Haridwar
Summary
Myself undersigned, Manish Joshi, Currently working as Assistant Manager, Quality Assurance having 14 years of experience in Pharmaceutical Quality Assurance and currently working with
Tata 1 mg Healthcare Solutions as Assistant Manager Private Label and have reviously worked with Organization i.e. Macleods Pharmaceuticals , Windlas Healthcare Pvt Ltd Dehradun ,Sun Pharmaceutical Industries Ltd. and exposure of facing Regulatory audits and Customer Audits and well versed with Current Regulatory Norms and Requirements .
CURRENTLY looking for a job in your esteemed organization, where can excel myself . So, herewith enclosing curriculum vitae Please, consider candidature for the suitable post in Quality Assurance Department. I assure you to prove myself, if selected & I would therefore be obliged if you give me an opportunity. s.
Overview
14
14
years of professional experience
Work History
Assistant Manager
Tata 1 mg Healthcare Solutions
Haridwar
01.2024 - Current
- Contract Manufacturing and Compliance at Vendor
Site for Tata 1 mg. - Documents Review.
- Handling Market Complaints and Customer
Complaints. - Trending of Data
- Vendor Audit
- Product Compliance at Manufacturing Site
- Vendor Qualification
Quality Assurance Manager
Dental Products of India,Rudrapur ( ISO 13485-2016 Certified Firm )
Rudrapur
02.2023 - 12.2023
- Developed and implemented quality assurance policies and procedures.
- Reviewed customer complaints and identified trends in order to develop corrective action plans.
- Conducted internal audits of processes, products, and systems to ensure compliance with quality standards.
- Evaluated supplier performance against pre-defined criteria and negotiated contract terms accordingly.
- Provided guidance on process improvements and best practices in order to maintain high levels of product quality.
- Investigated customer feedback and developed strategies for addressing complaints quickly and efficiently.
- Performed root cause analysis on non-conforming materials or products in order to determine appropriate corrective actions.
Quality Manager
Klokter Life Sciences Pvt Ltd., Rambha, Subsidiary of Zee Laboratories
Karnal
12.2022 - 01.2023
- Preparation and Execution of Process Validation Protocols
- RCA and Investigation
- Audit Compliance
- Document Review and Approval.
- Batch Release
Assistant Manager Q.A
Ambe Phytoextracts Pvt. Ltd.
Pauri,Garhwal
02.2022 - 11.2022
- Process Validation (Preparation,
Review of Protocol and Reports). - Product Hold Time Studies. (Preparation, Review of
Protocol and Reports). - Internal Audits (Certified Internal Auditor from Intercert),
Conducting Internal Audits. - Review of Report Master Batch Production
Review and Approval. - Facing Customer and Certification Audits.
- Resolving Customer Queries.
- Audit Compliance.
- CAPA Implementation and Effectiveness Checks.
- QMS Handling.
- Training.
- Document Review and Approval.
- SOP Preparation and Review.
Senior QA Executive
Macleods Pharmaceuticals Ltd.
Baddi,H.P
10.2017 - 01.2022
- PROCESS VALIDATION and Hold Time Study Protocol
Preparation ,Compilation ,Execution and Review of
Process Validation. - Process Verification, Process
Evaluation and Hold time Protocols and Reports. - Sampling of Product / material at various Stages
during Process and report review, coordination with
IPQA, and other departments for Implementation and
execution of Validation Activities. - SOP Preparation and Imparting Training.
- Review of manufacturing
documents such as BMR, BPR etc. - Handling of QMS
activities e.g., manufacturing (shop floor)
investigation, CAPA monitoring and change control
review for new / site transfer products. - Query Response Preparation as per Regulatory and Customer Requirement.
- Initiating Change controls.
- Submission of Documents for Regulatory Filings.
- Preparation of Validation Strategy
Executive QA
WINDLAS HEALTHCARE PVT. LIMITED
Dehradun
06.2016 - 09.2017
- In process checkup at dispensing to
packing stage of tablets /capsules manufacturing. - Calibration of IPQA Instruments Calibration and
Verification of Analytical Balance. - Ensure compliance of raw material, finished product, packing material with respect to established specification.
- To assure c-GMP and other regulatory compliance during all
manufacturing activities
Officer Quality Assurance
Sun Pharmaceutical Industries Ltd.
Ranipool,Sikkim
12.2013 - 03.2016
- PROCESS VALIDATION and Hold Time Study
Preparation ,Compilation ,Execution and Review of
Process Validation, Process Verification, Process
Evaluation and Hold time Protocols and Reports. - Sampling of Product / material at various Stages
during Process. CLEANING VALIDATION: - Preparation of Protocol and Report,
- Swab Sampling,Wash Water Sampling.
- IPQA (Line Clearance,
BMR/BPR Review, - Calibration and Verification of
IPQA Instruments, - Batch Release.
Officer Quality Assurance
G.S. Pharmbutor, U.S. Nagar , Uttarakhand
Rudrapur
08.2010 - 11.2013
- IPQA Activity.
- BMR & BPR Review for Batch Release.
- In process checkup at
dispensing to packing stage of tablets /capsules
manufacturing. - Calibration of D.T. Apparatus,
Friability apparatus, IR Moisture analyser.
Education
Pharmacy
H.I.P.R
Dehradun07-2010
Skills
- Certification
- Diploma In Pharmacy
- Sales monitoring
- Problem-solving aptitude
- Time management abilities
- Adaptability
- Task Prioritization
E X P E R I E N C E
13 Years 0 Month
Education
- 2010, uttarakhand technical university, 64%
- 2002, CBSE, English, 60-64.9%
- 1999, CBSE, English, 60-64.9%
Assistant Manager
(+91) 9997167240, write2memanish@gmail.com, Haridwar
M A N I S H
JOSHI
Languages
- English
- Hindi
Languages
Hindi
First Language
English
Upper Intermediate (B2)
B2
Timeline
Assistant Manager
Tata 1 mg Healthcare Solutions
01.2024 - Current
Quality Assurance Manager
Dental Products of India,Rudrapur ( ISO 13485-2016 Certified Firm )
02.2023 - 12.2023
Quality Manager
Klokter Life Sciences Pvt Ltd., Rambha, Subsidiary of Zee Laboratories
12.2022 - 01.2023
Assistant Manager Q.A
Ambe Phytoextracts Pvt. Ltd.
02.2022 - 11.2022
Senior QA Executive
Macleods Pharmaceuticals Ltd.
10.2017 - 01.2022
Executive QA
WINDLAS HEALTHCARE PVT. LIMITED
06.2016 - 09.2017
Officer Quality Assurance
Sun Pharmaceutical Industries Ltd.
12.2013 - 03.2016
Officer Quality Assurance
G.S. Pharmbutor, U.S. Nagar , Uttarakhand
08.2010 - 11.2013
Pharmacy
H.I.P.R
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