PV Compliance Specialist job opportunity at Abbott.

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DatePosted 9 Days Ago bot
Abbott PV Compliance Specialist
Experience: General
Pattern: full-time
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degreeMBA
loacation India - Mumbai, India
loacation India - Mumbai....India

      JOB DESCRIPTION: Primary Job Function: To provide support in the establishment, maintenance and development of the PV compliance monitoring system. Review and data entry of metrics in compliance tracking systems and tools. Metric collection and preparation of the regular management reports Core Job Responsibilities: •       Collection of compliance data within GPV and other stakeholders of the PV- and medical device vigilance system within the agreed timelines. •       Maintains and further develops the compliance monitoring system and compliance tracking databases with the support of IT. •       Collates metrics and drafts compliance overviews (Key Performance Indicators (KPls), PV Compliance Summaries). •       Requests non-compliance information I corrective/preventive actions when not provided by the non-compliant party. •       Performs regular CAPA reviews and follow-up with responsible organization in case of quality issues •       Manages the tracking of non-compliance information/ corrective/preventive actions and generates periodic reviews of compliance data and trending of root causes. •       Initiates investigations of non-compliance occurrences and documents investigation findings and proposes solutions according to the process defined within GPV. •       Assists in the liaison with relevant interfaces to ensure compliance is monitored for GPV through relevant KPls. •       Participates in training of relevant personnel on Compliance relevant topics (e.g. Affiliate tracking of submissions, CAPA Management Tool). •       Escalates to the Head PV System & Compliance, and if applicable the QPPV, any serious compliance or performance issues in order to take immediate action (corrective - or preventative action).       The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.       JOB FAMILY: Product Development       DIVISION: EPD Established Pharma          LOCATION: India > Mumbai : BKC Building       ADDITIONAL LOCATIONS:       WORK SHIFT: Standard       TRAVEL: Not specified       MEDICAL SURVEILLANCE: Not Applicable       SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)                  

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