Job description

  • Posted date 15 November 2021
  • LocationDublin
  • Job type Temp
  • SalaryNegotiable
  • Discipline Life Sciences
  • ReferenceJO-2109-477191

Quality (Stability) Data Analytics


Job Purpose:

Responsible for developing and sustaining the Pfizer data aggregation platform for quality control and data analysis of Stability studies for the site. Support statistical activities across the site associated with investigations and continuous improvement using process data and to provide innovative leadership in the application of analytic techniques to increasingly complex and diverse data sets.


This role is focused on providing high quality statistical support to stability programs in relation to regulatory submissions for products tested at the site. This support includes developing and sustaining the evolving data aggregation and reporting quality control and analysis platform informa. Support and statistical guidance for laboratory investigations. Delivery of routine statistical support to assure continued compliance within the general expectations of cGLPs for products manufactured in the network.

The contents of this document are not intended to be exhaustive and additional duties as may be directed by the QA Manager

Job Responsibilities:

  • Create Informa builds to support QA Stability data analytics in line with site and global procedures
  • Identify and promote continuous improvements
  • Maintain procedures in relation to Informa use
  • Provide data analytics support for APQRs, regulatory filings and investigations as applicable
  • Review changes that may impact upon Informa builds
  • Collaborate closely with key project stakeholders in the quality control environment on the provision of statistical services that support regulatory submissions for stability filings within timelines and escalate when necessary.
  • Provide statistical support to the QC laboratory organization when required during investigations, new product introduction or change implementation in commercial laboratory operations. Technical support may involve trouble-shooting and analysis to support identification of root cause.
  • Provision of solutions that lead to colleagues being able to conduct their own data analyses rather than using our statisticians.
  • Developing performance analytical solutions for continuous and time series data produced during batch processing.
  • Support data aggregation solutions for continuous and time series data analysis.


General

  • Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.
  • Participate in cross functional teams as required to provide consultative support on quality related issues.
  • Provide support; authors; review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.


People/ Values

  • Strong interpersonal skills with an ability to work independently across sites and teams.
  • Highly motivated, proactive and persistent.
  • Demonstrates a ‘can do’ attitude.
  • Self aware.
  • Adapts to change, responds positively with a sense of urgency.
  • Effective communication (verbal, written).
  • Ability to matrix-work effortlessly across team and organizational/hierarchical boundaries.
  • A team player by preference.


Education/Experience:

  • Advanced degree in statistics, biostatistics, computer science, engineering or related field is advantageous.
  • Knowledge of statistical tools, languages and methodologies (6-Sigma, Process capability, R, Python etc.) and associated software packages.
  • Capability to provide statistical guidance to cross-functional teams is advantageous.
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

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