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Clinical Research Quality

Location:
Atlanta, Georgia, United States
Salary:
30-35 per hour
Posted:
June 26, 2019

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Resume:

Vinaykumar Priyanka Pagadala

****, ******* ******* *****,

Norcross,

Phone: 470-***-****

Georgia-30092

Email: ac9o6t@r.postjobfree.com

PROFESSIONAL SUMMARY:

Self motivated, detail oriented quality control chemist with 3 years experience in Quality control wet laboratory in pharmaceutical industry with additional knowledge in QA related procedures. Seeking a professional environment where i can apply both my practical and also documentation handling and writing skills.

SKILLS:

•Strong knowledge of wet lab methods with expertise in raw material and packaging material sampling analysis and interpretation of results.

•SOP preparation.

•Handling of QA related proceudres.

•Strong command of Quality Control processes/systems

•Knowledge of safe lab practices, lab techniques and quality management principles.

•Certified in Chemical analysis and Quality Management.

•Strong time management.

•Good organizational skills, verbal/written communication skills and attention to detail.

•Troubleshooting.

•Knowledge in usage of IT tools.

•Excellent written and oral communication skills. Ability to communicate effectively at all levels within the externally and within the company.

WORK EXPERIENCE:

Senior Chemist - 04/2016 to 11/2016

Celon Laboratories Pvt Ltd Hyderabad, Telangana

Documentation work:

Preparation of SOPs and STPs

Handling of QA related procedures like Change control and change authorization documents. Vendor Qualification procedures.

Initiate and investigate the OOS results in quality control lab investigations.

Occasionally assisting incidents raised in analytical testing procedures.

Review and process data Interpret test results and ensure that they meet specifications, enter data into the computer, maintain instrument logbooks, laboratory worksheets and all relevant documentation according to cGMP documentation practices, review all information, and compile information into report form.

Review paperwork and documentation from other chemists

Participate in quality and efficiency improvement initiatives

QC Chemist - 11/2013 to 03/2016

Synthokem Labs Private Limited Hyderabad, Telangana

Operation and Calibration of Analytical balance, pH meter, Conductivity meter, Melting Point Apparatus, KF apparatus, UV, IR.

Preparation and Standardisation of all volumetric solutions.

Sampling and analysis and of all Key and non-key raw materials as per sampling procedure and issuing approved labels.

Sampling and analysis of all Packaging Materials and issuing approved labels.

Retesting of all Raw materials and packaging materials.

Cleaned and organized laboratory and ensured availability of supplies.

Provided inventory control of reagents, chemicals and supplies using proper labeling and computerized management systems.

Preparation of reagents.

Handling of all lab chemicals and primary standards.

Control/retention sample management.

Handling of vendor qualification procedure of new vendor (of Raw Material and Packaging material).

Reviewing of all QC related reports.

Online entry of log books and registers on daily basis.

Follow and maintain cGLPs, GTP, SOPs and STPs.

Internal and external audits coordination.

Documentation work interrelated to QA and QC:

Handling out of specification(OOS).

Preparation of SOPs and STPs.

Handling of change control procedures.

Knowledge in incidents.

Knowledge in vendor qualification procedure.

EDUCATIONAL QUALIFICATION:

•M.Sc(Biochemistry) from RGR Siddhanthi College, Osmania University, Hyderabad

•B.Sc(Biochemistry) from St.Francis Degree College, Begumpet, Hyderabad.

•Intermediate from St.Francis Junior college, Secunderabad.

ADDITIONAL QUALIFICATION:

•PG DIPLOMA in Chemical analysis and Quality management

Hyderabad Central University(HCU).

•Certificate course in Biostatistics.

ST. Francis College for Women

•Clinical Research and Clinical data Management Training

Clinnovo Clinical Research Institute.



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