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Assistant Manager-QA

9.00 to 12.00 Years   Delhi   12 Dec, 2022
Sygene
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    • Overall adherence to safe practices and procedures of oneself and the teams aligned.
    • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards.
    • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
    • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
    • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.
    • Compliance to Syngene s quality standards at all times.
    • Hold self and their teams accountable for the achievement of safety goals.
    • Govern and Review safety metrics from time to time.
    • Handling and management of Analytical QA pertaining to Biologics.
    • Handling of customer projects and attending internal PRM to ensure the project related activities are delivered as per timeline.
    • Quality Control documents review and approval.
    • Review and approval of documents related to CSV, LIMS, over all qualification activity, protocols, reports etc.
    • Review and approval of the analytical testing records.
    • Review and approval of Analytical Method Validation, Analytical Method Transfer, protocol and report as per current SOP.
    • Review and approval of stability summary and stability reports generated by QC.
    • Handling and being part of the investigations related to Deviations, Laboratory Incidents, Out of Calibrations, Out of Specifications, CAPA and Out of Trend.
    • Handling & management of Deviations, Laboratory Incidents. Coordinating in identifying the root cause investigations with CAPA identification, approval.
    • Handling, review, evaluation of Change Control, verification, and implementation of the Corrective and Preventive Action.
    Educational Qualification: Master of Science Technical/functional Skills:
    • Preparation and review of QA SOPs.
    • Review, approval of RM/PM/Consumables analysis reports and release on SAP.
    • Coordination in preparation and review of the QA SOPs in-line with current pharmaceutical guidelines.
    • Responding to queries providing support to customer/regulatory on analytical related documents, requests as per the customer/regulatory requirement.
    • Coordinating and conducting the internal audit.
    • To ensure implementation of all EHSS norms to create safe working environment.
    • Issuance of documents (annexures, ODS, calibration sheets, log sheets etc.).
    • Training of employees on various aspects like Good Documentation Practices and Good Laboratory Practices.
    Experience: 9-12 years of experience Behavioral Skills:
    • Aggressive but assertive on task completion.
    • High influencing skills to complete the task at hand.
    • Ability to provide solutions for complex problems.
    • Eye for detail.
    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 :
root causesalesaccountsanimal healthbankingmiscontinuous improvement facilitation

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