SATYENDU SUNDAR RAY

*th Cross, Ittamadu Main road, Banashankari 3rd Stage, Bangalore, 560 085,

Karnataka, India,

+91-984*******

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-

984-***-****

Contact this candidate