Arpit Tyagi
Sealaqui Dehradun Uttarakhand
Summary
Accomplished professional with extensive experience at Natco Pharma Limited in supplier management and team leadership, specializing in GMP/GDP compliance. Successfully conducted over 160 supplier audits and spearheaded quality assurance initiatives, resulting in enhanced supplier performance and operational efficiency. Demonstrated ability to innovate while maintaining rigorous quality standards. Career goals include further advancing quality improvement processes within the pharmaceutical sector.
Overview
13
13
years of professional experience
Work History
Assistant Manager Corporate Quality Assurance
Tirupati Medicare Limited (Poanta Sahib)
Paonta Sahib Himachal Pradesh
02.2022 - Current
- Management and qualification of new, alternate, and existing suppliers/vendors of raw (API/excipients/nutrients/herbal extracts) materials and packaging materials. Leading a team of five members.
- Leading all supplier audits as per ICH Q7, WHO GMP guidance for RM, ISO 15378, and BIS guidance for PM, as per the annual audit schedule and completion of audit compliance.
- Actively completed more than 100 supplier audits of raw materials (RM) and more than 60 audits of packaging materials (PM), both physical and virtual.
- Presentation of supplier performance/rating to management in each quarter, along with a comprehensive annual supplier rating review.
- Preparation of a risk assessment report in case of alternate vendors.
- Preparation of the vendor audit schedule.
- Providing cGMP and process-related training to own colleagues and plant employees.
- Communicating with the vendor to get the audit date, and to plan the audit.
Quality Assurance Executive
Natco Pharma Limited (EU GMP Certified )
Selaqui Dehradun Uttarakhand
10.2015 - 07.2022
- Market Complaint: To prepare and investigate the market complaint received from consumers/customers by using various tools like 6M, Why-Why, Pareto analysis, etc.
- APQR: Preparation and review of the annual product quality review.
- Supplier/Vendor Qualification.
- Maintain vendor source list and QI information in SAP HANA.
- Approved vendor list preparation with the help of SAP HANA.
- Updation of MRP of existing products and issuance and retrieval of related records.
- Management of external customer audits and timely closure of audit compliance.
- In-process Quality Assurance of oral solid dosage forms.
- Leading a team of 10 members to cover all in-process activities under complete cGMP compliance for solid and liquid dosages.
- Preparation of the process validation, cleaning validation protocol, and report.
- Perform process validation and cleaning validation.
- Periodic review and updating of existing SOPs of IPQA by incorporating all changes.
- Rejection analysis of rejections generated during packing by applying Pareto analysis.
- Deviation: Handling deviation due to departure from any established procedure, SOP, or any unidentified incident.
- CAPA: Handling corrective and preventive actions identified by or for continuous improvement in process, facility, equipment, and results from market compliance or deviation investigations.
- GAP Analysis: Periodic review and preparation of respective SOPs with GAP analysis.
- Handling of Control Samples.
- Handling of issuance and retrieval of documents.
Quality Assurance Officer
Cris Pharma Limited
Selaqui Dehradun Uttarakhand
01.2014 - 10.2015
- In-process quality checks associated with the production, packaging, and warehouse. To check online documentation and review BMR and BPR after the completion of the operation.
- Handling of Noncompliance, CAPA, and Deviation on the production floor.
- Handling of instruments: Hardness Tester, D.T. Apparatus, friability test apparatus, and leak test apparatus.
- SAP-related work is done on the floor.
- Participate in validation-related work done on the production floor.
Packing Supervisor
Mepromax Life Sciences
Selaqui Dehradun Uttarakhand
06.2012 - 07.2013
- Handling of finished products, primary, and secondary packaging activity.
- Handling of Manpower.
- To fill out online documentation, such as BMR, BPR, and logbook, during operation.
- Preparation of Packing Line BPR.
- Communication with the warehouse for dispensing of packaging material.
- Reconciliation of packing material and product yield in BPR.
Education
Bachelor of Pharmacy - Pharmaceutical Medicine
Gyani Inder Singh Institute (U.T.U.)
Dehradun Uttarakahand06-2012
Diploma In Pharmacy (D. Pharma) - Pharmaceutical Medicine & Hospital Pharmacy
Gyani Inder Singh Institute (U.T.U.)
Dehradun Uttarakhand06-2009
Skills
- Supplier management
- Supplier auditing
- Risk assessment
- Vendor qualification
- Market complaint investigation
- cGMP training
- SAP Management
- Validation and Qualification
- Time management: Work prioritization based on management requirements, and targets
- Team management: Development of team members for multitasking, and support to achieve the key responsibilities
- Simplification and innovation: Review of key operating procedures as per current guidelines, and updating of procedures, minimizing the gaps between actual required procedures and SOPs
- Ownership: Continue monitoring the system, and ensure GMP/GDP compliance across the department
Languages
English
First Language
National and International regulatory audits
- Have faced and successfully completed EU GMP audit more than 2 times, WHO GMP Audit more than 3 times, Kenya and Uganda regulatory audits more than 3 times.
National and International customer audits
- Have faced and successfully completed customer audits like Herbalife nutrition, Sanofi, Pfizer, Merck, Sun Pharma, Cipla, Lupin, Dr. Reddy etc.
Personal Details
- Date of Birth : 06/02/1991
- Marital Status : Married
Declaration
- I am solemnly declare that the statements and details given above are correct and upto the best of my knowledge and behalf.
Arpit Tyagi
Timeline
Assistant Manager Corporate Quality Assurance
Tirupati Medicare Limited (Poanta Sahib)
02.2022 - Current
Quality Assurance Executive
Natco Pharma Limited (EU GMP Certified )
10.2015 - 07.2022
Quality Assurance Officer
Cris Pharma Limited
01.2014 - 10.2015
Packing Supervisor
Mepromax Life Sciences
06.2012 - 07.2013
Bachelor of Pharmacy - Pharmaceutical Medicine
Gyani Inder Singh Institute (U.T.U.)
Diploma In Pharmacy (D. Pharma) - Pharmaceutical Medicine & Hospital Pharmacy
Gyani Inder Singh Institute (U.T.U.)
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