CSV Consultant (Team Lead)
Sanzyme Pvt.ltd
Keywords
SAP Applications
Unit Testing
Databases
Data Integrity
Enterprise Resource Planning
GNU Compiler Collection
Systems Development Life Cycle
Quality Management
Raw Data
SAP Quality Management
Skills
SAP, CSV, GCP, Test Scripts, SAP QM, Unit testing, SDLC, ERP, data integrity, data management system, databases, quality management system, raw data, QLMS, Windows, M.S. Office, GCC, FDA
Project history
03/2018
-
10/2018
Project 1 :
Client: Sanzyme Pvt.ltd
Project: SAP Support
Role: CSV Consultant (Team Lead)
Duration: March 2018 to October 2018
SAP Environment: SAP ECC 6.0
Industry Type: Pharmacy
Roles/Responsibilities:
* Verified, clarified and signed-off of the functional requirements/functional
specification.
* Developed and reviewed validation plans, Validation reports, and Traceability Matrix.
* Prepared and executed OQ, PQ documentation.
* Developed SOPs and compiled Training Manuals for the new working environment.
* Documented strategy for maintaining the Validated State.
* Worked extensively with the QA team for designing Test Plan and develop the Test
Scripts for the User Acceptance Testing.
* Addressed GxP, GCP, GMP FDA, CFR part 2-11, approach to compliance issues,
and summarized the outstanding problems and issues.
* Communicated the daily operations of the validation team to the management and
assured that the master plans, protocols and reports are generated, reviewed and
approved within predetermined timelines.
* Experience in Preparation and review of Protocols as per guidelines and FDA regulations
* Experience in Developing and reviewing User Requirement Specifications (URS), Functional
Requirements Specification (FRS) and Requirement Traceability Matrix (RTM) Documents
* Experience in Good Documentation Practices.
* Worked extensively with the QA team for designing Test Plan and develop the Test Scripts for the
User Acceptance Testing.
* Verified, clarified and signed-off of the functional requirements/functional specification
Client: Sanzyme Pvt.ltd
Project: SAP Support
Role: CSV Consultant (Team Lead)
Duration: March 2018 to October 2018
SAP Environment: SAP ECC 6.0
Industry Type: Pharmacy
Roles/Responsibilities:
* Verified, clarified and signed-off of the functional requirements/functional
specification.
* Developed and reviewed validation plans, Validation reports, and Traceability Matrix.
* Prepared and executed OQ, PQ documentation.
* Developed SOPs and compiled Training Manuals for the new working environment.
* Documented strategy for maintaining the Validated State.
* Worked extensively with the QA team for designing Test Plan and develop the Test
Scripts for the User Acceptance Testing.
* Addressed GxP, GCP, GMP FDA, CFR part 2-11, approach to compliance issues,
and summarized the outstanding problems and issues.
* Communicated the daily operations of the validation team to the management and
assured that the master plans, protocols and reports are generated, reviewed and
approved within predetermined timelines.
* Experience in Preparation and review of Protocols as per guidelines and FDA regulations
* Experience in Developing and reviewing User Requirement Specifications (URS), Functional
Requirements Specification (FRS) and Requirement Traceability Matrix (RTM) Documents
* Experience in Good Documentation Practices.
* Worked extensively with the QA team for designing Test Plan and develop the Test Scripts for the
User Acceptance Testing.
* Verified, clarified and signed-off of the functional requirements/functional specification
09/2017
-
04/2018
Officer Quality control
Mylan Laboratories
Roles/ Responsibilities:
* Responsible preparation of specifications, standard test procedures, and standard operating
procedures.
* Working in SAP and caliber LIMS software
* To coordinate with various departments for completion of work assignments.
* Compilation of stability data.
* Maintenance of laboratory worksheets.
* Verification of method transfer and method validation data.
* To follow the cGMP and GLP in work area.
* Responsible preparation of specifications, standard test procedures, and standard operating
procedures.
* Working in SAP and caliber LIMS software
* To coordinate with various departments for completion of work assignments.
* Compilation of stability data.
* Maintenance of laboratory worksheets.
* Verification of method transfer and method validation data.
* To follow the cGMP and GLP in work area.
03/2016
-
08/2017
Senior Analytical Research Associate in A R&D
Orbicular Private Limited
Roles/ Responsibilities:
* Verified Audit Trails, logical security and user privileges.
* Developed SOPs, Protocols and Project Plans.
* Development and Stability analysis for HPLC Assay, Related Substances for Ophthalmic products
Injectables and Suspension Forms.
* Working in Audit compliance team regarding clinical trails
* Responsible for overall activities of instrumentation lab and release of materials.
* Ensure GLP compliance in laboratory and participate Self-inspection related activities
* To co-ordinate with various departments for completion of work assignment
* Maintenance of Laboratory Research notebooks
* Preparations of Analytical method development reports.
* To follow the cGMP and GLP in work area.
* Verified Audit Trails, logical security and user privileges.
* Developed SOPs, Protocols and Project Plans.
* Development and Stability analysis for HPLC Assay, Related Substances for Ophthalmic products
Injectables and Suspension Forms.
* Working in Audit compliance team regarding clinical trails
* Responsible for overall activities of instrumentation lab and release of materials.
* Ensure GLP compliance in laboratory and participate Self-inspection related activities
* To co-ordinate with various departments for completion of work assignment
* Maintenance of Laboratory Research notebooks
* Preparations of Analytical method development reports.
* To follow the cGMP and GLP in work area.
12/2013
-
02/2016
Quality Control Officer Grade-I in QC
Medreich Limited
Roles/ Responsibilities:
* Responsible for all SAP activity in Quality control.
* Configured and Implemented Inspections Lot, Inspection Lot Creation, Inspections for Goods
Movement, Inspections for Repetitive Manufacturing, Inspections Triggered by release of Orders.
* Participate in SAP QM activities.
* Preparation of SOPs, Protocols and Specifications
* Results Recording; Defined Process Inspection Results, Process-Optimized Results Recording, Input
Processing for Measured Values
* Designed and Configured Defects Recording for Quality Inspections
* Experience in closing of equipment calibration orders
* Responsible for overall activities of instrumentation lab and release of materials.
* Practical Hand in using and troubleshooting QC instruments like: HPLC, UV-VISIBLE
Spectrophotometer, Dissolution, Water by KF, pH meter, Stability Chambers, Friability and
Hardness tester etc.
* Preparation of trends against Innovator samples.
* Ensure GLP compliance in laboratory and participate Self-inspection related activities.
* To monitor data integrity in the electronic data management system and ensure that databases
contain accurate data related to products.
* To monitor compliance with the specific requirements of the quality management system.
* To perform the Analysis, reporting as assigned by group leader.
* To submit the analytical documents with all details to group leader for further checking and
needful
* To complete the work assigned time to time by the superiors. To analyze the other samples viz.
finished products, In-process samples, Raw Materials or any samples offered by group leader as and
when required.
* Analysis of cleaning samples by UV
* Analysis stability studies
* To follow the cGMP and GLP in work area
* Preparation and review of raw data worksheets as per the relevant specification
* Experience in creation of Manual inspection lots and results recording in SAP
* Maintenance of validation documents
* Responsible for all SAP activity in Quality control.
* Configured and Implemented Inspections Lot, Inspection Lot Creation, Inspections for Goods
Movement, Inspections for Repetitive Manufacturing, Inspections Triggered by release of Orders.
* Participate in SAP QM activities.
* Preparation of SOPs, Protocols and Specifications
* Results Recording; Defined Process Inspection Results, Process-Optimized Results Recording, Input
Processing for Measured Values
* Designed and Configured Defects Recording for Quality Inspections
* Experience in closing of equipment calibration orders
* Responsible for overall activities of instrumentation lab and release of materials.
* Practical Hand in using and troubleshooting QC instruments like: HPLC, UV-VISIBLE
Spectrophotometer, Dissolution, Water by KF, pH meter, Stability Chambers, Friability and
Hardness tester etc.
* Preparation of trends against Innovator samples.
* Ensure GLP compliance in laboratory and participate Self-inspection related activities.
* To monitor data integrity in the electronic data management system and ensure that databases
contain accurate data related to products.
* To monitor compliance with the specific requirements of the quality management system.
* To perform the Analysis, reporting as assigned by group leader.
* To submit the analytical documents with all details to group leader for further checking and
needful
* To complete the work assigned time to time by the superiors. To analyze the other samples viz.
finished products, In-process samples, Raw Materials or any samples offered by group leader as and
when required.
* Analysis of cleaning samples by UV
* Analysis stability studies
* To follow the cGMP and GLP in work area
* Preparation and review of raw data worksheets as per the relevant specification
* Experience in creation of Manual inspection lots and results recording in SAP
* Maintenance of validation documents
Local Availability
Only available in these countries:
India
