Snapshot :
A result-oriented professional around 8 Years 6 month experience in Quality Assurance. Presently associated with Psychotropics India Limited, Haridwar as a Dy. Manager in QA documentation cell.
Multifaceted growth of the organization and self as a part of the system through hard work and realistic approach in the field of Quality Assurance.
Professional Summary :
Yadvendra Singh Sisodia is M.Sc. in Microbiology from Jiwaji University. I have around 9 years of experience. Out of these 4.5 years in sterile formulation and remaining in tablet, capsule, Oral liquid, Powder (ORS, Dry powder) and hormones.
During these years of professional carrier I have worked at Trainee to Dy. Manager in quality assurance in Zydus Cadila healthcare Ltd. ,Relax Pharmaceuticals Pvt. Ltd. Unit-I (Mankind group of company), Galpha laboratories Limited (Alkem group Company) and Psychotropic India Ltd.
The turning point of my carrier when I joined M/s Relax pharmaceutical. & worked as a core member in Five member team for WHO GMP task & other semi-regulated countries like Ethiopia, Uganda, & successfully got certification. The core area was QMS & trainings. In Galpha Laboratories limited work as core team member for MHRA/EUGMP task and successfully received QP certification. Recently successfully done ANVISA in Psychotropics India Limited without any critical non-conformance and got certificate.
Area of Expertise :
Quality Management System :-
** Change control
** Deviation
** Self Inspection
** Market Complaint
** Document Preparation/Review
** Standard Operation procedure
** Site Master File
** Batch manufacturing records
Vendor evaluation :-
** Contract testing laboratory
** API & Excipients manufacture/supplier
Annual Product Quality Review :
** Oral Solid doses form
** Oral Liquid
Hold time study :
** Product
** Equipment
Qualification & Validation :-
** HVAC
** Water
** Equipments
** Process
Mentored less experienced QA members as to the skills needed
Audit Faced :
** Team member of 3 times in audit preparation for WHO-c GMP by CDSCO and One time In WHO Zenva at Zydus Cadila
International audit faced like
** USFDA
** MHRA
** EU GMP
** ANVISA
** TGA
** MCC
** MOH- IRAN
** MOH- SUDAN
** MOH- ETHIOPIA
** MOH- SYRIYA
** MOH- YAMEN
** MOH- UGANDA
** MOH- TANZANIA
** MOH- KENYA
** MOH- SUDAN
** MOH- GHANA
** MOH- UKRAINE
** MOH- Other
Employment Profile :
1. Psychotropics India Limited, Haridwar :
Psychotropics India Limited is a WHO GMP, ANVISA, Philippians, African & Gulf country like KENYA, UGANDA ETHIOPIA, SYRIYA etc. approved certified company, which has acquired a reputation of an innovative company, over the years.
Duration : 01 August 2015 to till date Designation: Dy. Manager-QA
Works as a document In-charge and lead the documentation cell in Regulatory and internal audit and works as a core member in ANVISA audit task and successfully received Audit approval
2. Galpha Laboratories Ltd. Baddi (Alkem Group of Company) :
Galpha Laboratories Ltd. Baddi is dynamic SAP oriented company and has state of the art manufacturing facilities in baddi which is EU-GMP, WHO GMP certified company.
Duration : Aug. 2014 to July 2015 Designation: Executive - Q.A
Works as a document In-charge and lead the documentation cell in Regulatory and internal audit and works as a core member in EUGMP & MHRA audit task and successfully received QP approval.
3. Relax Pharmaceutical Pvt. Ltd (Group comapny of Mankind Pharma), Paonta Sahib :
Relax Pharmaceutical Pvt.
Ltd unit-I, (Group company of Mankind Pharma) is SAP oriented which has acquired a reputation of an innovative company, over the years. We have been steadfastly sowing the basics of Innovation, Quality and Service to reap excellence.
Duration : June 2011 to Aug 2014
Designation :Officer Q.A
4. Zydus Cadila Healthcare Ltd, Ahmadabad :
A USFDA, MHRA, MCC, certified company engaged in manufacturing of Human Rabies Vaccine and other sterile formulation (SVP and LVP) of international quality and has emerged as a leading health management company of India.
Duration : November 2008 to June 2011
Designation : Technical supervisor
Job Profile :
Quality Management System :
** Handling of documentation related activities during Domestic & International Audits.
** Assist QA Head and Quality Head during audits and Maintain QMS at plant.
** Preparation, review ,control, distribution and retrieval of SOPs and ensure compliance of SOPs
** Handling of QMS related documents (Change control, Deviation, CAPA and incident etc.)
** Understand & supports to QA head in Risk Management, CAPA, Failure investigation and its reports.
** To ensure self-inspections and quality audits are carried out as per schedule and ensure compliance.
** Handling of Market complaint and quality related complaints.
** To prepare Site Master File (Plant Master File), Quality Policy and VMP.
** To prepare qualification protocol & execute the protocol (i.e. HVAC ,Water validation, Area & Equipment)
** To prepare and involve on execution of Disinfectant validation, Hold time study of garments, 70 % IPA Hold time study & efficacy validation protocol, Hold time study of Purified water at 2 to 8º C.
** To coordinate various validation activities e.g. process, equipment/facility etc.
** Review the Annual Product Review Report of OSD and Oral liquids products
** Giving training to personnel and evaluation of its effectiveness.
** Handling of Training programmes as a training coordinator, Preparation of Master calendar and management of training records.
** Periodic review the training file and training calendars to compliance training system at plant.
** Review the Vendor questioners and maintain the vendor audits documents.
Other Works :
** Handling of numbering system for Equipment/Instruments and Facility.
** To provide required data to CQA & regulatory.
** Management of Master & controlled document and handling and execution of controlled documents, Art Work, Log books, obsolete document and filled documents.
** Handling of organogram & Job responsibility to concern.
** Handling and control of Price list and maintain signature log of the all employees
** Handling of all documentations for approval of contract parties and dealing with.
** Having Exposure of Vendor audit and approval Process, Product recall procedure and Mock trial.
Education :
** M.Sc. Microbiology with 65% from Jiwaji University in 2008.
** B.Sc. Microbiology with 61% from Jiwaji University in 2006.
IT Skills :
** Internet skills
** MS office
** Software handling
Personal Details :
Date of Birth : 14th July 1986
Address : Yadvendra Singh Sisodia, 880 B Block Anand nagar Bahodhapur, Lashkar Gwalior (M.P.) 474012
Father’s Name : Sh. N.S. Sisodia
Nationality : Indian
Language Known : Hindi, English,
Current Salary : CTC: 6.0 Lac
Expected Salary : Negotiable
Declaration :
I do hereby declare that the information stated above is true to the best of my knowledge and belief.
Date :
Place : Haridwar, India