Senior Analysis Investigator

Abbott

Abbott

Witney, UK
Posted on Tuesday, July 9, 2024

Position Summary from Legacy System
This field includes Main Responsibilities imported from Legacy System.
Support ADC Internal and External customers by providing accurate complaint trends in a timely manner.
To review and approve the initial investigations into trends highlighted from the monthly complaint metrics and by batch
trending.
To carry out extended investigations into trends highlighted from the monthly complaint metrics and by batch trending.
To prepare and present trends and investigations at review meetings including Site Management Review, PQA Tracking and
Trending, Abbreviated Management Review, and Extended Management Review.


MAIN RESPONSIBILITIES
Additional Main Responsibilities from Legacy System
This field includes Main Responsibilities imported from Legacy System.
Support ADC Internal customers by providing accurate complaint trends in a timely manner.
Support ADC External customers by providing accurate complaint trends and investigation data during external audits.
Additional Main Responsibilities from Legacy System
Support a work environment that ensures team effectiveness.
Support other areas within the Complaint Handling Group as required.
Coordinate the work of the analysis investigators.
Liaise with UK, Ireland and US PQA groups as required for confirmed trends that require Product Impact Evaluation.
To review and approve the initial investigations into trends highlighted from the monthly complaint metrics and by batch
trending.
Carry out extended investigations into trends highlighted from the monthly complaint metrics, and document the results of
the investigations.
Maintain a stand alone numbering system for the extended investigations.
Maintain a stand alone numbering system for trend requests and maintain the trend log.
Carry out extended investigations into trends highlighted from the by batch trending.
Schedule follow up activities as required from retain testing.
Lead any follow up investigations required as a result of the extended trend investigations.
To prepare and present trends and investigations at review meetings including Site Management Review, PQA Tracking and
Trending, Abbreviated Management Review, and Extended Management Review.
Ensure working area is maintained to regulatory standard at all times.
Responsible for maintaining the effectiveness of the quality system at the site in accordance with divisional requirements and
applicable regulations.
Perform complaint review for the Post Market Surveillance of Precision strips according to the timelines established.
To work with management and other team members to ensure the Health and Safety of self and fellow employees.
Conform to all relevant legislation and company Health and Safety policies.
To work with the management team and other team members to facilitate the introduction of new products into the
Complaint Handling Group.
Be proactive in recommending cost savings through complaint process improvements. and data quality, in line with Business
Excellence initiatives.


Accountability/Scope/Budget from Legacy System
This field includes Accountability/Scope/Budget information imported from Legacy System.
Responsible for conducting investigations into trends highlighted from the monthly complaint metrics and confirmed trend
alerts in a timely manner.
Failure to meet these requirements can lead to delays in communicating field issues to senior management, delaying potential
product recalls.
There is also a compliance risk if reports are not generated in a timely manner, and maintained to regulatory standards.
Supervisory/Management Responsibilities from Legacy System
This field includes Supervisory/Management Responsibilities information imported from Legacy Syste