Soumya Ranjan Mishra
Quality Control Manager
Hyderabad
Summary
Ambitious and creative professional with 17 years of experience in Pharmaceutical Quality with demonstrated history of proficiency in the areas of Quality Control. Adept in investigation activities utilizing root-cause and problem-solving methodologies as well as support CAPA development and implementation. Analyze, develop and improve quality systems and associated business processes to achieve compliance with global regulatory requirements. Unbiased, practical and working style based on facts, figures & findings and good in conflict resolution and escalation. Proficient with health Authority inspections (USFDA, MHRA, ANVISA, TGA, MCC, RUSSIA, UKRAINE). Proficient with Lean Six Sigma methods and Microsoft Office.
Overview
17
17
years of professional experience
Work History
Manager: Quality Management System
Biocon Ltd.
03.2021 - Current
- Supervising a team of 6 members including managerial responsibilities such as allocation of resources, organization of projects and performance reviews
- Provided options for safe work environment, improvement of efficiency, reduction of human errors, cost saving initiatives and lean operations
- Collaborated closely with External vendors, External testing laboratories, production, Quality Assurance, Supply chain management, Regulatory affairs and R&D teams which created cross-functional teamwork and seamless communication
- Responsible to review and ensure the current Good Manufacturing Practices(cGMP) across the lab as per the laid down procedures
- To Carry out investigations on the Laboratory Incidents, Out of Specification (OOS), Out of Trend) (OOT), Out of Calibration (OOC), Deviations, and Provide Corrective Action Preventive Action (CAPA) as applicable
- Responsible to investigate the incidents / deviations occurred across the lab during analysis
- Ensuring CAPA effectiveness & verification for the implemented CAPA’s
- Ensuring all-time readiness for audit and a subject matter expert for interaction during regulatory audits
- Responsible for Conducting training sessions as per revised Specifications and ensure training completion based on training needs for employees
- Responsible for implementation of LIMS, e-signature in standalone instruments and Empower custom field calculations
- To prepare and review of investigation reports, risk assessments, impact assessments protocols and reports (Hypothesis, method validations, transfers and qualification) as applicable
- Responsible to review / verify / check the Certificate of Analysis
- Responsible to ensure completion annual trends wherever applicable, like lab incidents, water and environment etc
- Responsible to ensure training completion based on training needs for employees followed by analyst qualification activities
- Review of daily monitoring of temperature and humidity for stability chambers and sample pullout activities
- Review of product specifications (Finished Product (FP)/In-process (IP)/Raw Material (RM)/Packing material (PM)/Cleaning Sample (CS) etc.)
- Responsible for the review/approvals of all activity in SAP module and LIMS
- Responsible to provide Site acceptance for the Quality Management System documents received from other sites
- Review the audit trails for the chromatographic and non-chromatographic systems
- Preparation/Review of Cleaning validation/Process validation and Hold time study protocols in co-ordination with QA
Assistant Manager: Quality Control
Aurobindo Pharma Ltd.
10.2020 - 03.2021
- Responsible for laboratory compliance, Audit trail review in Empower and standalone instruments in quality control department
- Review of analytical documents of finished product section and release of batches
- Initiation of process nonconformance (PNC), Out of trend, Out of specification, Implementation of full kitting in finished product section for reduction of TAT and increase of SLA
Team Leader Quality Control
Dr.Reddy’s Laboratories Ltd.
01.2016 - 08.2020
- Supervised a team of 16 personnel including managerial responsibilities such as allocation of resources, organization of projects and performance reviews
- Provided options for safe work environment, improvement of efficiency, reduction of deviations, cost saving initiatives and lean operations
- Provided technical guidance to junior analysts on method and instrument trouble shooting
- Collaborated closely with External vendors, External testing laboratories, production, Quality Assurance, Supply chain management, Regulatory affairs and R&D teams which created cross-functional teamwork and seamless communication
- Handled raw materials, Stability studies, Method transfer activities, excel calculation sheet validation, statistical evaluation by using Minitab, preparation and review of SOP’s, change management, batch release, training and mentoring, various Quality Management software like SAP, LIMS, QMS and OCMS
- Ensured all-time readiness for audit and a subject matter expert for interaction during regulatory audits
- Received Dr
- Anji Reddy Award for excellence in 2018 as part of best quality team for reduction of invalid OOS, achieving more than 90% SLA for batch release and reduction of TAT
- Received Certificate from CEO for best simplification idea contribution in 2016
- Laboratory Management system, Warehouse management system, SAP resulted in increased compliance
- Spearheaded the implementation of Potency calculation of APIs in MES (Manufacturing Execution system) for dispensing of raw materials without manual intervention prevented calculation errors leading to seamless production without Quality issues
- Productivity enhancement through better employee engagement with role rotation and job enrichment (30% Optimized)
- Involved and contributed for the digitalization process, conversion of manual activities to electronic in applied Lean tools and methodology (Lean daily Management, 5s) to foster continuous improvement to processes and procedures resulting in the decrease of standard lead time (SLA) of sample per analyst from and decrease in turnaround time (TAT)
- Developed talent, implemented succession planning and mentored team members for higher responsibilities, which facilitated internal movement without obstruction of the work
- Contributed for the reduction in HPLC Breakdown & Reduction in Notifications by implementing hot water flushing of the system and cleaning of suction filters in consultation with service engineer and incorporating the same in the SOP resulted in improved occupancy by 15%
- Commended by Management for successfully implementing Reduced Testing procedure for about 80 Raw Materials & contribution in the implementation of Raman Spectrometer for Identification of Raw materials which resulted in saving of more than 30 lakhs per annum
- Established stability data for twenty volumetric solutions, Reagents and Indicators, which provided backup for solution storage and usage, increased regulatory compliance
Senior Executive to Assistant Manager
Dr. Reddy’s Laboratories Ltd.
06.2010 - 12.2015
- Performed, In-process, Finished product, process validation and Stability samples analysis
- Maintained HPLC columns, Placebos, Chemicals, Reagents and Indicators, Volumetric solutions
- Handled all major analytical instruments like HPLC, Dissolution apparatus, UV, IR, and Potentiometer
- Review of analytical documents generated in QC and stability laboratory, Review and submission of stability data
- Training and qualification of newly joined analysts through LMS (Learning management system) and refreshment training for existing employees
- Handling of Review team for the stability department, review and approval of stability protocols
- Harmonization of specifications and Standard testing procedures, gap assessment of Russia and Ukraine specifications and standard testing procedures against normative documents
- Initiation and closure of change controls and review of Tech-packs
Management Staff
Cipla Ltd.
01.2008 - 05.2010
- Analyzed in process, finished, stability study of Submission, validation and commercial batches analysis
- Complied stability data and reviewed stability data
- Analytical testing include ID, Assay, Content uniformity, uniformity of dosage units, Dissolution, impurity tests, Residual solvents, water content, bulk density, sieve analysis by using instruments HPLC, GC, UV-Vis & IR spectrometry, Karl fisher titration, Dissolution etc
Education
M.Sc. - Organic Chemistry
Berhampur University
Berhampur, OdishaB.Sc. - Chemistry Honours
Berhampur University
Berhampur, OdishaSkills
Quality Management
Professional Development
- Trained as 'Train the trainer'
- Trained on 'All time audit Readiness'
- Trained on 'Effective Auditor Engagement'
- Trained on 'Technical writing skills'
Timeline
Manager: Quality Management System
Biocon Ltd.
03.2021 - Current
Assistant Manager: Quality Control
Aurobindo Pharma Ltd.
10.2020 - 03.2021
Team Leader Quality Control
Dr.Reddy’s Laboratories Ltd.
01.2016 - 08.2020
Senior Executive to Assistant Manager
Dr. Reddy’s Laboratories Ltd.
06.2010 - 12.2015
Management Staff
Cipla Ltd.
01.2008 - 05.2010
M.Sc. - Organic Chemistry
Berhampur University
B.Sc. - Chemistry Honours
Berhampur University
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