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Junior Manager

6.00 to 10.00 Years   Delhi   04 Apr, 2023
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

    • Preparation and review of Equipment, Utility qualification relevant procedure and ensuring execution compliance as per approved SOP.
    • Responsible for Preparation of Protocols and reports inline to site specific SOP at Biologics and Injectable facilities.
    • Review of procedures, URS, impact assessment, Risk assessment, protocols & reports for qualification & validations for facility/Area, equipment & utilities in facilities.
    • Coordinate the activities of qualification/validation with the stakeholder departments, ensuring the timely completion of projects and project milestones.
    • Ensure QA validation oversight during FAT, commissioning /SAT and IQ, OQ & PQ as per qualification requirements & documentation.
    • Review of Design documents and execution of IQ, OQ and PQ activity of the new facility/product/process critical equipment along with documentation in place in time as per defined procedure.
    • Review of facility, Utility related drawings/layouts (for ex., pressure differential, AHU zoning, area classification, equipment layouts, piping drawings, isometric drawings etc.).
    • Ensure QA validation oversight during periodic validation of critical process equipment, utilities such as HVAC systems water system and compressed air systems revalidations.
    • Technical evaluation for facility /utility, equipment modifications.
    • Supporting to prepare VMP Calendar. Ensuring execution of Re-qualification activities as per VMP calendar tolerance.
    • Support external client audits and regulatory inspections.
    • Preparation of Technical write up to comply audit requirements.
    Educational Qualification: M.Sc. / M. Pharm/ B. Pharm/ /B. Tech Technical/functional Skills:
    • Technical knowledge in Biologics and Injectable.
    • Should have minimum 5 years of work experience in Pharmaceutical Validation systems (Facilities, Utilities, Equipment, and Computerized Systems).
    • Computer System Validation (CSV) deliverable preparation/review.
    • Life Science QMS procedures.
    • Should be knowledgeable on validation guidelines per different regulatory requirements and Industrial bodies, e.g., ICHQ2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, and PICS.
    • Interpersonal skills to establish collaboration with cross-functional teams
    • Establish good Interpersonal skills with cross-functional teams.
    Experience: 6 Years + experience in the pharmaceutical injectable and biological industry. Behavioural Skills:
    • Should have good communication skill and should be a good team player.
    • Ability to work successfully in a dynamic, ambiguous environment.
    • Ability to meet tight deadlines and prioritize workloads.
    Competences Excellent written and verbal communication skills Good interpersonal skills Analytical strengths and high trouble shooting ability,

Keyskills :
sapsafetycommissioningmechanicaltroubleshootingproject engineering managementrisk assessmentisometric drawingsposition management

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