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Clinical QA Auditor

6.00 to 9.00 Years   Bangalore, Chennai, Hyderabad, Kolkata   04 Jan, 2022
Job LocationBangalore, Chennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaAudit
EmploymentTypeFull-time

Job Description

Designation: Assistant ManagerJob Location: Semicon park, BangaloreDepartment:Quality Assurance-GCPAbout SyngeneIncorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Key Responsibilities:

  • To perform the role as Clinical QA auditor to verify compliance with respect to ICH-GCP, applicable regulatory requirements and Study Protocol for Clinical, Pharmacy, Biometrics, clinical data management and Medical writing activities for BA/BE and phase-1 studies.
  • 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.Pharm, 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: 06 09 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 :
bioanalyticalequal employment opportunitycontinuous improvement facilitationanimal healthcalibrationclinical dataquality assuranceclinical data managementvendor auditcommitment towards worksopdecodingsix sigma

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