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Clinical Trial - QA Manager

6.00 to 9.00 Years   Hyderabad   08 Aug, 2022
Syngene International Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Designation: Assistant Manager- Clinical Trials - QA Job Location: Semicon park, Bangalore Department: Quality Assurance-GCP About Syngene Incorporated 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 Trials - QA auditor to verify compliance with respect to ICH-GCP, applicable regulatory requirements and Study Protocol for Clinical site, Pharmacy, Biometrics, clinical data management and Medical writing activities for patient based (Phase I, II, III and IV) studies.
    • GCP clinical Trial QA auditor with 6-9 years of experience in performing Clinical trials investigational sites GCP QA audits across India and other international destinations.
    • Collate data for clinical quality metrics and report.
    • Perform system and study audits with respect to 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 Sciences Technical/functional Skills:
    • Sound technical Knowledge in Clinical trial 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 years Behavioral 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 :
quality controlinspectiondeliveryvendor auditautomationquality

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