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Principal Scientist - ARD-SBL

14.00 to 16.00 Years   Chennai   10 Dec, 2022
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other SoftwareBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Key Responsibilities:
    • Ensure validation and stability sample analysis are completed in time.
    • Approval of documents including but not limited to validation protocol, validation summary, method report wherever applicable.
    • Interaction with BMS/ARD personnel for technical troubleshooting.
    • Responsible for communicating project status ,resource requirements or any other requirements to achieve target timelines.
    • Investigation and closure of OOS, OOC, Laboratory incidences, deviation and Non-Conformity as applicable.
    • Provides adequate resources for laboratory investigations to evaluate quality of material/product.
    • Ensure that analytical failures such as OOS, OOC, deviations and Laboratory incidences are adequately investigated, root cause identified, CAPA identified and implemented.
    • Review of Change controls, Standard Operating Procedure, Instrument Operating Procedures, General analytical Methods and specifications.
    • Identifying the possible apparoches for the continous improvement.
    • Interaction with client and Project team for the smooth functioning of project related activities.
    • Ensures responses to audit observations are submitted in timely manner.
    • Delegates responsibilities to team members for effective execution of validation and stability analysis.
    • To ensure that processes needed for the quality management system are established, implemented and maintained as per current regulatory requirements.
    • To ensure compliance to Good Manufacturing Practices, Good Laboratory practices, Good Documentation practices, Data integrity and other regulatory requirements.
    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
    • Miscellaneous lab responsibilities
    Educational Qualifications: M.Sc. Chemistry or M. Pharm Technical/Functional Skills:
    • The candidate should have a good educational and theoretical, analytical chemistry background
    • Good knowledge of analytical techniques
    • The candidate should understand instrument calibration, method validation, and routine analysis
    • Good understanding of documentation as per GxP requirements (electronic notebook)
    • The candidate should have good proficiency in MS office tools
    • Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
    • Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, etc. is must
    Experience: 16-18 years with M.Sc. or 14-16 years with M. Pharm for 6-I 19-21 years with M.Sc. or 16-19 years with M.Pharm for 6-II Behavioral Skills:
    • Strong commitment toward work and a high level of dedication, enthusiasm, and motivation
    • Good speaking-listening-writing skills, attention to detail, proactive self-starter
    • Ability to work successfully in a dynamic environment
    • Should be able to work in a team and flexible for working in shifts.
    • Ability to meet tight deadlines and prioritize workloads.
    ,

Keyskills :
researchvalidationhplcapiprocess developmentequal employment opportunity

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