SATYENDU SUNDAR RAY
*th Cross, Ittamadu Main road, Banashankari 3rd Stage, Bangalore, 560 085,
Karnataka, India,
PERSONAL SUMMARY
A highly efficient, methodical and skilled quality assurance supervisor who
has considerable experience of developing and implementing effective
quality assurance procedures and structures in a manufacturing and
corporate environment. Possessing a good understanding of the essentials of
safety, quality and regulatory requirements. Strong customer service
experience and a background of achievement in supporting all levels of
management & working to set schedules and deadlines. Proficient in QMS
track wise system, SAP transactions. Excellent written and verbal
communication and negotiating skills, Strong planning and organization
skills
Looking for an organization where I can utilize my skills and be an asset
to the employer.
WORK EXPERIENCE:
Reviewer-II, Jun 2010 to till date
Apotex Inc., Bangalore
> Develop change management strategies, conduct stakeholder analysis,
impact assessments and devise appropriate plans.
> Ensure all change activities are completed in accordance with project
plans and time frames.
> Analyze effectiveness of change management approach and make
recommendations for improvement.
> Management and review of non-conforming events including product
recalls, customer complaints and internal non-conforming events.
In co-ordination with all the departments plan the development, review
and implementation of the Quality Management System to ensure
Regulatory requirements are met and best practice is achieved.
> Root cause analysis of Quality related issue and Implementation of
CAPA (Corrective and Preventive Action) through proper documentation.
Executive-QAD, from Oct.2008 to May.2010
Kemwell Pvt. Ltd., Bangalore
> Responsible for monitoring and maintaining quality and compliance
targets.
> Monitoring and auditing of products to ensure high standards of
quality.
> Ensuring products comply with legislation and quality assurance codes.
> To participate in training a team of skilled staff and to promote
healthy working relationships within the organisation.
> Identify training needs and recommendations to improve customer
experience.
> Performing in process quality assurance checks for semi-solid dosages
and liquid orals.
> Ensured periodic validation and Re-Validation related to process and
Equipments/Instruments whenever required
> Keeping quality documentation up to date.
> Making sure that all QA records, data & information are available to
the managers.
> Ensuring non-conforming products are identified and placed on
restriction.
> Responsible for the review and update of the programme quality plans.
> Awareness of regulatory requirement and customer service expectations.
> To investigate customer complaints and provide a timely response in
accordance with defined procedures.
> Preparation, revision and review of Quality assurance procedures,
Batch Records, review of analytical procedures and reports.
> Provide weekly and monthly reports to senior managers on performance.
> Preparing and analysing information for the purpose of Management
Review.
Asst.Officer R&D, from Feb.2007 to Aug.2008
Jagdale Scientific Research Foundation, Bangalore
Organize, design and execute experiments/trials to support Product
development.
Participate in multi-disciplinary project teams through the complete
product development cycle.
> Facilitates information and technology transfer between different
development and/or manufacturing sites
Write and review technical documents including formulation development
protocols and reports, SOPs, specifications, and other necessary
technical documents.
> Work with Technical Services on process development to support
commercial scale up
> Subjecting the approved formulations for stability study and following
up with the stability analysis results.
> Interacting with other departments like Quality control, Production,
Logistics, Engineering etc. for the execution of trial batches as per
the Organizational requirement.
Lecturer-Pharmacology, from Oct.2006 to Jan.2007
NCP, Bangalore
> To contribute in educating the next generation of professional
pharmacists.
> To counsel students pertaining to their career objectives and goals.
> To perform other academic related duties.
ACADEMIC QUALIFICTIONS:
M.Pharm - Pharmacology
Utkal University 2004 - 2006
B.Pharm - Pharmaceutical Science
Utkal University 2000 - 2004
AWARDS AND HONORS:
District level Winner in Debate, Essay and Science Quiz competitions.
COMPUTER SKILLS:
MS-Office, Windows 98, 2000 & XP, HTML, C & Internet
PROJECT:
Anti-Ulcer activity of peels of Musa Paradisiaca.
STRENGTHS:
> Good communication skills and able to interact and explain concepts
and plans clearly to senior managers.
> Excellent listening skills.
> Possessing a agile business mind.
> Having a professional attitude and an imaginative approach.
> Strong influencing skills.
> A team player who is able to work easily with others.
PERSONAL DETAILS:
Father's Name : Dr.Dibakar Behera
Date of Birth : 23-06-1981
Gender : Male
Marital Status : Married
Languages Known : English, Hindi, Kannada and
Oriya
Nationality : Indian
Permanent Address : Dr.Dibakar Behera
Ramsagar,
Dt-Balasore
State-Orissa
Phone-