Part Time Quality Assurance Auditor Delhi : CRQA

[muthukalee]

QA AUDITORS-Part Time / Project Basis – All Major Cities

CRQA – www.crqa.in is an upcoming clinical research quality assurance firm, established by the senior professionals from the clinical research and pharmaceutical industry.

CRQA is looking for QA and Auditing professionals on part time or assignment basis at various locations in India with auditing experience in the following areas:
* GCP Audits
* Clinical Operations
* CRO Audits
* Central Lab and Bio analytical Lab Audits
* Clinical Trial Supply Audits
* IRB Audits
* System Audits
* Data Management Audits
* Essential Document Audits
* Pharmacovigilance Audits
* GLP / GMP Audits
* SOP Development
* Regulatory Inspections Preparations

KEY RESPONSIBILITIES
* Perform QA audits of clinical trial data and records in order to assure compliance with client SOPs, study protocols, GCP guidelines, relevant regulations and ISO 9000 requirements.
* Plan and conduct regular and random QA audits.
* Perform quality system audits and contract audits for Sponsors.
* Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
* As an auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the sponsors on all QA issues, including audit planning and review of audit results.
* QA Training.

QUALIFICATION & EXPERIENCE
* Qualification in medicine, science and/or other relevant discipline and appropriate experience.
* Previous experience in Quality Assurance auditing – 2 – 5 years.
* Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
* Ability to review and evaluate clinical data / records.
* Excellent communication and interpersonal skills.

These are part time / project assignment based positions. Only apply if you are interested in working on part time / project basis. Kindly apply in confidence with your detailed CV detailing your QA / Audit experience to bd@crqa.in – www.crqa.in.

CRQA India, Office
CRQA
C-55, Ist Floor, Preet Vihar
Delhi-110092, India

[Guest]

Priyadarshini C.R.
Educational Qualification
Qualification
School/College Year of passing
(Aggregate %)
M.Sc Biotechnology Kumararani Meena Muthiah College of Arts and Science 2009 67%
B.Sc. Microbiology
Dr.MGR Janaki College of Arts and Science for Women 2007 67%
12th Standard Sri Ramakrishna Mission Saradha Vidyalaya Model Higher Secondary School, Chennai 2004 85%
10th Standard Sri Vidya Matriculation Higher Secondary School, Chennai 2002 75%
Work Experience
Employer : Micro Therapeutic Research Labs Pvt. Ltd. (July 2009 – April 2011)
Current Role : Research Associate - Quality Assurance
Responsibilities :
- Quality Assurance of the Bio-study raw data as per GLP/GCP Guidelines
- Preparation and reviewing of Standard Operating Procedures (QA SOPs) as per regulatory requirements and conducting training.
- Checking of Chromatographic and Clinical Raw data generated as per US-FDA & ICH-GCP Guidelines.
- Initiate inspection and supervise the calibration/maintenance of all the equipments (Chromatographic Column, Temperature Probe, Digital clock Slave, Thermo-hygrometer, etc.)
- Monitor completion of MV /Study activities (in-process) as per GLP and relevant SOP and current regulatory requirements (Quality wise).
- Review of SOP’s for the “Determination of Bio-analyte (Single/Multiple Analytes) concentrations in biological matrix (e.g. Human Plasma/Serum) By Ultra/High Performance Liquid Chromatography – Mass Spectrometric Technique”.
- Review of Method Validation and Bio-analytical Study reports.
Instruments worked on :
- Liquid Chromatography Tandem Mass spectrometry
- UPLC coupled with Waters API 3000
- HPLC & UPLC coupled with Waters API 3200
- UPLC coupled with Waters API 4000
- HPLC coupled with Waters Micro Mass
Softwares
- Analyst 1.4.1
- Analyst 1.4.2
- Mass lynx 4.1
- Analyst 1.5.2
Calibration :
- Shimadzu HPLC Calibration
- Alliance HPLC Calibration
- Micro Balance
Audits Went Through :
- US FDA Regulatory Audit
- ANVISA – Brazilian Regulatory Audit
- AAFSAPS – French Regulatory Audit
- CAP Regulatory Audit

Techniques Learnt :
Immunology Microbiology
a) Immunoelectrophoresis
- Counter Current Immuno Electrophoresis (CCIEP)
- Rocket Immuno Electrophoresis
b) Immunodiffusion techniques
- Ouchterlony Double Diffusion (ODD)
- Single Radial Immuno Diffusion (SRID)
c) ELISA (Demonstration)
d) Differential Counting
e) RBC & WBC Counting
f) Blotting techniques - Southern blotting, Northern blotting & Western blotting a) Cell Plate counting
b) Culturing of Microbes
c) Gram Staining
d) Acid-Fast Staining
e) Biochemical Tests for identification of Micro organisms
Genetics Chromatographic Techniques
a) Restriction Fragment Length Polymorphism (RFLP)
b) Polymerase Chain Reaction (PCR)
c) Isolation of DNA, RNA and Plasmid DNA
d) Restriction digestion techniques
a) Affinity Chromatography
b) Paper Chromatography
c) Thin Layer Chromatography (TLC)
d) Column Chromatography
Skills - Bio-informatics
- Tools : FASTA, BLAST
- Modeller 9v1 : Protein Modelling
- Auto Dock 4 : Docking Studies (Interactions between Protein and Ligand molecule)

Projects & Internship
Elite Bio-Science Foundation, Chennai – Bio-Informatics Intern
- Worked on tools like FASTA, BLAST, RASMOL, MODELLER 9v1 (Protein modeling), AutoDock 4 (Docking – Interactions between Protein and Ligand molecule
MEDISPAN, Chennai – Project Intern
- Successfully completed a project titled “High Performance Liquid Chromatography”
Bio-Informatics - Database Development
- Developed a database for diseases pertaining to metabolic systems
- The database has information related to 45 metabolic disorders. The information includes genes and proteins responsible for the disease
- Software Languages used : PERL, Html and MySQL
Areas of interest

- Bio-analysis
- Biotechnology
- Immunology
- Microbiology
- Bioinformatics

[Guest]

ABHISHEK SHARMA
CAREER OBJECTIVE : To diversify my skills while working with an organisation of high repute
EDUCATION QUALIFICATION :
¨ Passed M.A (Education) from C.C.S Univ. Meerut in 2010 with IInd Div.
¨ Passed M.A (Sociology) from C.C.S Univ. Meerut in 2008 with IInd Div.
¨ Passed B.A from C.C.S. Univ. Meerut in 2006 with IInd Div.
¨ Passed Intermediate (Science, Bio) from U.P Board in 2000 with IInd Div.
¨ Passed High School (Science, Math) from U.P Board in 1998 with IInd Div.
TECHNICAL/PROFESSIONAL QUALIFICATION :
¨ 1 Year diploma in Computer Hardware & Networking from JETKING, Hapur.
¨ 8 Month’s diploma in Office Automation & D.T.P from B.I.T.S, Hapur.
¨ 3 D-Studio from B.I.T.S, Hapur.
¨ 8 Month’s experience as a Photo Shop Designer in B.I.T.S, Hapur.
¨ WILCOM ES 65 Version 9 Training from IIGM Delhi.