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Clinical QA Auditor

6.00 to 10.00 Years   Delhi   26 Feb, 2021
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Perform and verify Clinical QA audit and Compliance activities with respect to Clinical HPU, Pharmacy, Biometrics, clinical data management and Medical writing functions. Collate data for clinical quality metrics and report. Perform system and facility audits with respect Clinical HPU, Pharmacy, Biometrics, clinical data management and Medical writing functions. Perform vendor audits based upon quality risk assessment. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Attend training on environment, health, and safety (EHS) measures imparted company.Educational Qualification: M.Sc. in Life SciencesTechnical/functional Skills: Sound technical Knowledge in Clinical BE /BA studies and pharmacology. Knowledge of Process excellence and Six sigma is preferred. To develop key performance and quality metrics, track and trend the data for analysis and interpretation.Experience: 03 06 yearsBehavioral Skills: Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be strong in Data Integrity. Should be a focused employee.Equal Opportunity Employer:It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
bioanalyticalcommitment towards worksopcontinuous improvement facilitationequal employment opportunityclinical data managementcalibrationdecodingquality assurance

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