Dynamic professional with extensive experience in strategic sourcing and procurement at Matrix Pharma Corp. Proven leadership in vendor qualification and risk mitigation, ensuring timely delivery of critical materials. Skilled in SAP MM and adept at fostering cross-functional collaboration, driving operational efficiency, and enhancing supplier relationships to support production goals.
Overview
16
16
years of professional experience
Work History
Deputy manager - Strategic sourcing for AVD & NPD
Matrix Pharma Corp. (Mylan Laboratories)
03.2021 - Current
Source Identification by using DWCP, ROW 2 & Google for GRM, KSM & Intermediate and coordination between source and internal team to get samples and complete the source qualification.
Responsible for qualifying at least minimum two vendors for each molecule to mitigate the risk with single sources.
Timely completion of Vendor Evaluation, Quality Agreements Sign-off, Audit clearance, Creation of MPN and approval of commercial & Technical assessment Sheets prior to scale up validation as per R&D Grid
Responsible to behave like a bridge between supplier and internal cross functional teams to get the necessary documentation like as technical package, supplier qualification forms, impurity and working standards support, etc... from the source and to comply with the SOP for qualification of source.
Responsible to play a key role to organize meetings with suppliers when technical support or issues arise by PDL, R&D & Site quality.
Responsible to co-ordinate with PDL team to implement the CIP process by introducing new suppliers who are in cost effective, quality and quantity in market.
Responsible to release the purchase orders and continuous follow-up with suppliers to deliver the materials on time (RM, KSM & Intermediates) which are required to fulfill the source qualification followed by lab & plant validation.
Responsible to co-ordinate with internal cross functional teams (PPIC, Procurement, site quality, PDL & R&D) to create/unblock the MPNs for all materials to place the orders and proceed with execution.
Well co-ordination with suppliers to get the CMC documents and submission to regulatory for filling and clearance, and responsible to get required documents from the supplier when the support is needed by regulatory affairs team to respond any regulatory query.
Responsible to co-ordinate with CQA, Site QAD and supplier to plan for qualification/Periodical audit with respect to supplier qualification SOP and followed by placing the valid audit report and quality agreements.
Preparation of Monthly MIS & RM concerns.
Commercial Plant Procurement - Domestic
Mylan Labs
02.2020 - 03.2021
Responsible to float enquires to approved vendors for bidding, after receipt of the bids, prepare Quote Comparative Analysis Statement. Identifying the right vendor by considering cost & quality of the goods delivered and placing the order for the right source.
Well-coordinated with vendors & transporters for delivery of materials as per required WH schedule during COVID pandemic situation.
Responsible to coordinate with finance team to release the payments as per the due dates.
Co-ordinated with planning team (PPIC) to get the requirement of raw materials month wise.
Co- ordinated with suppliers/Manufacturers for timely delivery of raw materials.
Assist in gathering information on new vendors, sources, market, current processes and prices; Provide inputs based on issues faced in day-to-day operations.
Collect the data on vendor performance and share inputs to management.
Identify materials of high risk and make advance procurement planning.
Making immediate remedial / replacement plans for RM rejections to avoid production stoppage.
Operational Improvisation:
Review with PPIC, warehouse to prioritize the deliveries aligning the production plan.
To work with vendors on increasing the Batch Size and packing as per input Batch qty for the RMs which will help in reduction of QC Testing time and improve productivity.
Acting on all raised OOS RM’s and getting final investigation and CAPA from suppliers and removing the rejected materials from plant within 15 working days of OOS confirmation.
Obtaining credit notes in time against rejected quantities.
Sr. Chemist, officer and Executive
Mylan Laboratories Limited
07.2012 - 02.2020
Worked as Sr. Chemist, officer and Executive in contract manufacturing services department which is the part of corporate quality assurance at Mylan Laboratories Limited.
Responsibilities include Quality systems development and compliance at contract manufacturing facilities of Mylan Laboratories Limited.
Proficiency in preparation of Master batch production record and validation protocols, change controls, Facility/Equipment qualifications & process validations.
Well versed with cGMP, ISO Tools and handled audits by agencies USFDA, KFDA, WHO, EDQM & ISO and other overseas customers.
RESPONSIBILITIES & LEARNING’S in Contract Manufacturing Services
Review of Contract Manufacturer related documents
Review of Contract Manufacturer Qualification documents, Change controls, deviations and Complaints. Proposes appropriate action plans.
Statutory documents
Responsible to get the statutory documents from and maintain.
Conducting Vendor audits (CMUs)
Ensuring vendor audit schedule preparation and audits are completed as per the schedule and review of compliance reports for effectiveness of corrective & preventive actions.
Technology transfer
Co-ordinates technology transfer between internal sites and CMUs
Commercial agreements (CCs)
Responsible for calculating overhead costing and preparation of commercial agreements as per the actual CCs from the validation batches at CMU.
Process & Cleaning Validations
Coordinating validation activities and reviewing Validation Protocols and Summary reports for validation.
Handling of Change Controls
Evaluation of Potential Impact on Quality of the product depending on the nature and scope of the change.
Coordination with Regulatory Affairs
Coordination with RA for agency submissions, DMF deficiencies and queries to provide the response within specified timelines from the CMUs.
Handling of Deviations and OOS
Support CMUs to Investigate of Deviation and OOS to identify assignable root cause. Ensure tracking and effective implementation of CAPA
Ensuring IPQA Activities
Ensuring all time readiness at CMUs.
CMU visits
Responsible for conducting sudden surprise visits at CMUs and verification of stock details, batch executions and etc.
Sr. Executive in Compliance Department
Dr. Reddy’s Laboratories Limited
10.2010 - 06.2012
Worked as Sr. Executive in Compliance Department at Dr. Reddy’s, CTO-1, Had an experience in Production documentation.
Chemist in Quality Assurance
Divi’s Laboratories Limited
03.2009 - 09.2010
Previously, worked as chemist in Quality Assurance of Divi’s Laboratories Limited, Unit-2, and Vishakhapatnam. Had a multi-functional experience in the tenure with Divi’s. Started the career in production documentation (cGMP department), involved in imparting training for the employees and finally got the opportunity to work in Quality assurance by passing the internal tests.
Education
M.Sc - Chemistry
Acharya Nagarjuna University
Nagarjuna Nagar
B.Sc. - Chemistry
Acharya Nagarjuna University
Nagarjuna Nagar
Skills
Leadership and teamwork
Motivation and perseverance
Adaptability and flexibility
Task management and prioritization
Basic computer skills and Microsoft Office proficiency
SAP MM expertise
Languages
English, Telugu & Hindi.
Personal Information
Disclaimer
I hereby declare that the information mentioned above is true to the best of my knowledge. (Nanduri. Pattabhi Rama Raju)