Praveen Singh Sisodia
Gwalior
Summary
Dedicated & motivated Project Lead-LIMS with 19 years of experience in various industries such as Pharmaceuticals and API with proficiency in quality operations with different sophisticated instruments and equipment with illustrated experience in Quality control.
Overview
3
3
Languages
20
20
years of professional experience
Work History
Aurobindo
hyderabad
04.2019 - Current
- Performing Quality Control review of documents, protocols, policies, procedures and reports of undertaken miscellaneous studies
- Ensuring tests are carried out as per appropriate standard specification and verifying the correctness of results
- Responsible for reviewing implementation, tracking and archival of SOPs, their distribution, monitoring and control
- Evaluating and taking corrective actions whenever required
- Performing Internal Audit on site-specific files, master files and various others as per the local and international guidelines and regulatory requirements
- Responsible for approving sampling instructions, specifications, test methods and other quality control procedures.
- Responsible for change control, incident, deviations and maintaining QC records, Specification and all QMS documents
- Complete knowledge of operation and familiarity with various instruments including HPLC, GC, and TOC with good documentation and timely analysis and recording of stability data
- Responsible for Audit and compliance, good laboratory practices into the laboratory.
- QMS Activities-Initiation and closure of change controls, SOP revisions, CAPA, deviation and incidents
- Audit responses for Internal &CQA Audits, Tier1, 2, 3 &Trainings to team
- Determining and agreeing on in-house quality procedures, standards and specifications
- Inspecting and setting standards for quality on a regular basis
Project Lead: gLIMS(Labware V6)
Pfizer Ltd.
Aurangabad
06.2018 - 02.2019
- Managed team operations (15 people team): Oversaw the day-to-day activities surrounding the implementation of the gLIMS system including.
- Manage site deployment scope, timeline, risk and quality as Site Deployment Lead
- Identify site resources and monitor their performance and allocation for the project, and manage risks or issues prior to escalation.
- Collaborated with the Site Compliance Lead to develop the Site Validation strategy.
- Coordinated validation activities with site personnel to develop, review, and approve validation deliverables such as site test scripts and protocols.
- Coordinated with the Site QO Lead and the local leadership team to resolve issues.
- Defines the objects that will be included in each CYCLE as part of site master data planning activities. Communicates this with the work cell team to align on priorities. Evaluates Work In Progress needs and includes in CYCLE planning.
- Managed creation of key deliverables, including the site supplemental validation plan, the site training plan, the site SOP plan, and the site communications plan.
Team Leader-Calibre LIMS
Dr. Reddys
Hyderabad
12.2015 - 05.2018
- Led team of 15 in creating and updating LIMS masters for product, test, test plans, and TDTCs in LIMS-Calibre 3.2E and Labware LIMS V7, ensuring accurate documentation in a paperless laboratory.
- Led pharmaceutical production teams at Dr. Reddy's manufacturing site.
- Monitored batch records for compliance with quality standards and GMP procedures.
- Coordinated shift handovers for packaging, inspection, and dispensing activities to maintain operational continuity and efficiency.
Asst. Manager-Quality Control
Emcure
Pune
08.2014 - 11.2015
- Led 10-person team in planning and timely release of products. Coordinated with R&D to ensure methods' suitability. Transferred methods and analyzed in-process validation samples in QC.
- Coordinated cross-functional activities across Emcure's pharmaceutical operations and support teams.
- Coordinated cross-functional activities across Emcure pharmaceutical operations and support teams.
- Managed daily MIS reports for production, inventory, and dispatch tracking.
Section head/Reviewer (Chromatography section)
Cipla
Pithampur, Indore
01.2010 - 08.2014
- Closed incidences, CAPA, OOS, and OOT for oral dosage forms, ensuring compliance and quality of salbutamol, Lamivudine, and Zidovudine.
- Reviewed batch records, logbooks, and production documentation for compliance.
- Reviewed batch records, logbooks, and production documentation to ensure adherence to regulatory and quality standards.
- Coordinated daily production needs with quality, maintenance, and warehouse teams to streamline operations.
Analyst-Quality control
Lupin
Mandideep, Bhopal
01.2007 - 01.2010
- Performed GMP quality control testing for Lupin pharmaceutical raw materials and finished products.
- Worked as an analyst and responsible for analysis of In process samples, finished product samples. Conducted analysis of formulated broad-spectrum antibiotics, including oral syrups and suspensions, to validate product efficacy and safety.
- Calibrated analytical instruments and verified equipment readiness before testing runs.
- Documented laboratory results in controlled records and reviewed batch release data.
Education
M.Sc. - Applied Biochemistry
Jiwaji university
Gwalior, M.P.B.Sc. - chemistry
Vikram University
Ujjain, M.P.Higher Secondary - Biology
M.P. Board
BhopalHigh School -
Kendriya Vidyalaya, C.B.S.E. Board
DelhiSkills
- Quality Management Systems
- Regulatory Compliance
- Compliance management
- Expertise in Quality review and chromatographic techniques
- LIMS certified trainer
- Train the Trainer
- Analytical problem solving
- Comprehensive problem solving abilities
Comprehensive problem solving abilities, Attentive to my work, Change Management
Personal Information
- Gender: Male
- Marital Status: Married
HOBBIES:
- Gender: Male
- Marital Status: Married
Accomplishments
- Audit faced like USFDA, WHO, TGA, MHRA, ANVISA in the present and previous Companies.
- Consistently achieving targets with highest SPA(Sample per analyst)/Month.
- No Data integrity & safety violence during the period.
- Timely closures of CAPA, OOS, OOT, Incidences and change controls.
- “Things to do” list always updated for prior planning of upcoming departmental targets.
- Certified trainer in “Labware LIMS & Caliber LIMS (Laboratory information management system).
Declaration:
- Gender: Male
- Marital Status: Married
PERSONAL PROFILE:
- Gender: Male
- Marital Status: Married
Languages
English
First Language
Hindi
Proficient
C2
Marathi
Advanced
C1
Timeline
Aurobindo
04.2019 - Current
Project Lead: gLIMS(Labware V6)
Pfizer Ltd.
06.2018 - 02.2019
Team Leader-Calibre LIMS
Dr. Reddys
12.2015 - 05.2018
Asst. Manager-Quality Control
Emcure
08.2014 - 11.2015
Section head/Reviewer (Chromatography section)
Cipla
01.2010 - 08.2014
Analyst-Quality control
Lupin
01.2007 - 01.2010
M.Sc. - Applied Biochemistry
Jiwaji university
B.Sc. - chemistry
Vikram University
Higher Secondary - Biology
M.P. Board
High School -
Kendriya Vidyalaya, C.B.S.E. Board