Highlights:

Skills:Quality specialist, Quality assurance, Quality assurance, Quality assurance

Deputy Manager in Quality Assurance Department 08/2020 - current
Biocon Biologics, Bangalore, Karnataka India
Industry: BIOPHARMACEUTICALS
12+ years of Industrial experience in Quality Assurance Department. Core Competence: Implementing comprehensive quality management systems & procedures; developing related documentation formats, guidelines and quality systems while fulfilling GMP requirements. ? Leading the Quality Management System and Documentation activities. ? Responsible for Handling Track wise system for Quality management system ? Responsible for Handling Deviations , Change controls, CAPA,OOS ,OOT ,Market complaints and Investigation.
Overall Responsible for Quality Management System (QMS) and Documentation. Responsible for Change controls, Incidents, Deviations management and CAPA/ Investigations. ? Review of the MPCR BPCR SOPs and handling the different Bio similar products like Monoclonal antibodies (Bevacuzumab,Trastuzamab,Denosumab,GCSF, PEG-GCSF) ? Handling (creation, review, execution and approval ) of the QMS elements through track wise systems. ? Responsible for handling of OOS and OOTs. ? Responsible for handling the Internal Audits. ? Responsible for Vendor evaluation and qualification for raw materials and packaging materials. ? Responsible for implementation of Standard Operating Procedures (SOP’s). ? Overall Responsible for SAP (creation and updates of Material codes, Bill of Materials (BOM), Master recipes and Process orders, etc.). ? Responsible for preparation of Site master file and validation master file. ? Responsible for cGMP and Department Trainings based on LMS and offline. ? Review and approval of Protocol and Report. ? Responsible for Review of Batch Documents (BMR & BPR) via Documentum. ? Ensure compliance with cGMP/ GDP. ? Responsible for Document Control System (DCS) Management. ? Review and approval of pest control documents ? Risk assessment and management of Risk. ? Provide guidance to site Users and collaboration with Team to close the QMS elements on time to meet the ? KPIs ? Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews ensuring that trend programs and outputs are providing key indicators as to program efficacy--
Assistant Manager-Quality assurance 05/2019 - 07/2020
Omni active, Hosur, Tamilnadu India
Industry: Pharma
Overall taking care Quality Assurance Department
Preparation and review of QA and other department SOP’s. ? Handling of Quality management system ? Audit Compliance. ? Handling of CAPA Management system ? Handling of customer complaints and queries. ? Handling Validation Activities and Qualification Activities ? Review and approval of Questionnaires. ? Coordinate with team for internal audit and external audit. ? Approval of certificate of analysis and handling of dispatch activities. ? Review and approval of BMR,BPR. ? Review and approval of cross functional SOP’s & Documents. ? To implement and improve the existing Quality Management System. To provide relevant cGMP training to new entrants and retraining to all Qualified production / Quality Control/ Stores/ Quality Assurance--
Sr executive in Quality Assurance Department 10/2017 - 04/2019
Syngene international limited, Bangalore, Karnataka India
Industry: Pharmaceutical
overall taking care Qualiyy assurance department Responsibilities
Review of the Biologics products MPCR and BMRs ? Preparations of Audit observations reports and CAPA management Involved in SOP preparation in coordination with cross functional departments ? Handling of the change control management system ? Preparation and review of Annual Product Review reports ? Performing root cause analysis and CAPA management ? Handling of the deviations & market complaints ? Carrying out internal audit at sites ? Preparation of Annual product review--
Sr executive in Quality Assurance Department 06/2016 - 09/2017
Sun pharma, Chennai , Tamilnadu India
Industry: Pharmaceutical
Overall taking care QA responsibilities
Preparations of continue process verification protocols & reports ? Handling Validation Activities and Qualification Activities, ? Involved in SOP preparation in coordination with cross functional departments ? Preparation And review of Quality Risk Management Protocols ? Performing root cause analysis and CAPA management ? Handling Change Controls, Deviations, Product Recalls and IPQA activities ? Preparation and review of Annual Product Review reports ? Attending & resolving customer complaints and return goods ? Carrying out internal audit at sites ? Ensuring and resolving the Data Integrity issues ? Coordinating for completion of various regulatory audits such as USFDA, WHO, KFDA, EDQM--
Executive in Quality Assurance Department 10/2014 - 05/2016
Hetero labs, Vishakapatnam , Andhra Pradesh India
Industry: Pharmaceutical
Overall QA responsibilities
Preparation of Validation Protocols and Reports ? Preparation SOP’s and GMP related Document ? Preparation of process capability with Minitabsoftware ? Handling of QMS Activities ? Handling of Validation and Qualification Activities ? Preparation and review of Annual Product Review reports ? Ensuring GMP on Shop floor and all Related Areas ? Giving Training to Shop floor employees on GMP measures ? Coordinating for completion of various regulatory audits such as USFDA, WHO, EDQM--
Sr Assistant in Quality Assurance Department 08/2009 - 09/2014
Aurobindo pharma, Hyderabad , Telangana India
Industry: Pharmaceutical
Overall QA responsibilities
Review of Batch Production and control Records and Batch release.(ERP, Manual). ? Performed IPQA activities at sites required for cGMP ? Actively participation in Change evaluation, Implementation review and developing change control system effectively ? Handling of Qualifications(URS,DT,DQ,IQ,OQ,PQ) activity Responsible to review the deviations and monitor the proper root cause and close with corrective and preventive actions ? Identifying OOS (Out of specification) and OOT (Out of trend) ? Implementation and Distribution of Standard Operating Procedures ? Imparting training to shop floor employees oncGMP, SOPs ? Ensuring the implementation of cGMP in all departments ? Releasing the materials (Intermediates/API) as per the QA release SOP ? Successfully faced varied regulatory and customer audits as a team member (USFDA, TGA, MHRA, WHO,EDQM ).--

Andhra University 04/2006 - 04/2009
, , India
Degree: Bachelor's Degree
Major:Botany, zoology, chemistry
I have completed my bachelor science

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