![]() Maintains continuity among corporate, division, and local work teams by documenting and communicating actions, irregularities, and continuing needs.Achieves financial objectives by anticipating requirements submitting information for budget preparation scheduling expenditures monitoring costs analysing variances.Improves program and service quality by devising new applications updating procedures evaluating system results with users.Provides historical reference by developing and utilizing filing and retrieval systems.Completes special projects by organizing and coordinating information and requirements planning, arranging, and meeting schedules monitoring results.Purchases printed materials and forms by obtaining requirements negotiating price, quality, and delivery approving invoices.Provides communication systems by identifying needs evaluating options maintaining equipment approving invoices.Provides supplies by identifying needs for reception, switchboard, mailroom, and kitchen, establishing policies, procedures, and work schedules.Accomplishes staff results by communicating job expectations planning, monitoring, and appraising job results coaching, counselling, and disciplining employees initiating, coordinating, and enforcing systems, policies, and procedures.Maintains administrative staff by recruiting, selecting, orienting, and training employees maintaining a safe and secure work environment developing personal growth opportunities.Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.Ĭontribute towards the achievement of Quality Objectives. Independently handle complex work-stream related queries from internal and external stakeholders – proactively providing solutions or answers to their queries.Įnsure all project and administrative documents are properly archived in the prescribed repositories.īe aware of and comply with the QMS/ ISMS & PIMS Policy. Responsible for monitoring, ensuring training compliance and approving timesheets for team members.Ĭontribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.Ĭonstantly review process relating to the project and customer defined documentation as per internal guidelines Work closely with the team and client (as applicable) to identify and mitigate risks to meet the timelines, addresses/seeks clarity for queries, if any and escalates when necessary.Įnsure that all assigned goals (e.g., utilization and efficiency) are met for self and team as per set standards for the performance year. Is accountable to ensure that team performs with compliance to accepted quality and Keeping abreast of current regulations for global markets.įunctionally review the team’s work for accuracy and complianceĮnsure proper planning of the deliverable and foresee any risks that are likely to arise Support in regulatory audits for manufacturing sites. Ongoing submissions and present dashboard on monthly metrics/SLAs. Organizing and participating in project related meetings to provide status updates on the Regular update of database, and tracking tools to ensure current product information is ![]() Responsible for writing and review of CTD modules for all submissions.Ĭreation, review, assessment, and execution of initiated/assigned change controls.Ĭompliance to regulatory work processes, policies, and procedures Prepare gap assessment of existing documentation against the national regulations and provideĬoordinate with cross functional teams to collate required documentation. Technical review of all quality and administrative documents in line with current quality Variations, supplements, amendments, PSUR etc), response to Health Authority questions for globalĭevelopment / Execution of regulatory strategies and support product life cycle management. New marketing authorization applications, post approval activities (Annual report, Renewals, ![]() Prepare, review, and finalize the submission package of assigned product portfolios including
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