Job as Quality Specialist, Technology QM at Parexel

PAREXEL has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 54 countries around the world, and has over 9,500 employees.
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.

Post: Quality Specialist, Technology QM

Job Description:
Serve as a quality consultant to designated operational group(s). Activities include: identification of process improvement opportunities, process authoring and review, support for process re-engineering, providing GxP and process expertise to designated operational group(s), support for identification, management and prevention of project quality issues, providing audit and inspection support, and assist with the collection and reporting of project quality metrics as assigned.

Candidate Profile:
Experience in one or more of the following areas is required:
- EDC Database Set Up / Programming in InForm, RAVE, DataLabs or OC RDC
- SAS Programming
- CDISC/SDTM
- CTMS Set Up, preferably Impact
- EDMS Set Up, preferably OpenText's LiveLink

Experience in one or more of the following areas is preferred:
- Process/SOP development
- Audit hosting / response follow up
- Quality Issue / Corrective Action management

Experience in one or more of the following areas is advantageous:
- Computer Systems Validation / Systems Life Cycle
- Training development
- Training delivery.

Note: Candidates with relevant experience in Clincal Programming (OC, INFORM, RAVE etc) can send the CV to kirloskar.das@parexel.com

Additional Information:
Experience: 3-5 years
Location: Hyderabad / Secunderabad
Education: Any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: other