Apotex Hiring Associate/Sr Associate, GBS - Global QC Stability Data Analytics Apply Now
Job Summary
Responsible to summarize and review stability data to ensuring
that Apotex commercial products’ shelf lives are supported. Responsible to
perform Stability data trending for investigations and for Annual Stability
Summary Review packages for the APQRs to ensure compliance with established
timelines and Good Manufacturing Practices. Provide required stability data to
customers for their product compliance files.
Job Responsibilities
Prepare, review and publish Stability Summary Reports within
compliance time frame.
Prepare and provide summary reports for special projects and
product evaluations requested by internal or external customers.
Review Stability data from third party affiliates for compliance.
Perform Stability Impact Assessment for out-of-trend results
obtained at release for drug product as per approved procedures.
Perform shelf life extensions or reductions for product as
required and as per approved procedures.
Perform trend analysis as requested by the customers and as per
approved procedures.
Review and evaluate Stability data for the product to ensure that
no significant trends are developing that warrants attention and that the
approved shelf life continues to be justified.
Interpret statistical analysis from NWA.
Provide Annual Stability Review contribution packages to QA
Product Review group for the Annual Product Quality Review (APQR). Notify Team
Leader of any adverse trends detected.
Works as an effective team member to meet department goals,
sharing knowledge with team members.
Maintain compliance to all health and safety standards, Good
Manufacturing Practices, Good Documentation Practices and regulatory
requirements. Responsible and accountable for compliance with all aspects of
the local safety regulations, as well as Apotex’s Health and Safety policies,
and Safe Work Procedures.
Performs all work in support of our Corporate Values of Courage,
Collaboration, Pride and Perseverance; Demonstrates strong and visible support
of our values.
Initiate Change Control Records for shelf life extensions/reductions,
SOP’s as necessary.
All other duties as assigned.
Job Requirements
BSC. Degree or Diploma in a Life Sciences or related discipline.
4years to 10 Years experience in pharmaceutical industry.
Must have a good overall understanding of pharmaceutical
manufacturing & processes.
Strong organisational skills and able to work with minimum
supervision.
Excellent oral and written English communication skills.
Demonstrated knowledge of Stability requirements.
Self-starter, good interpersonal skills and results oriented team
player.
Ability to manage multiple priorities in a fast paced environment.
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