Represent QA for country launches and oversee related Change Controls,
Represent the QA function for the selection, approval and qualification of new suppliers in line with scope,
Maintain Quality Agreements up to date in line with the expansion plans,
Chair Management Review Board for major and critical product distribution issues,
Be the QA lead for investigation for deviations within regional scope,
Perform batch disposition for finished products and coordinate with QP/RP for final release,
Record, assess and reconcile Product Quality Complaints,
Develop and provide on the job training on Batch Disposition, Deviation, Complaints and Change Control to new hires as per scope of expertise,
Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
Act within compliance and legal requirements as well as within company guidelines,
REQUIREMENTS
Academic degree in natural or applied sciences preferred
Firsthand experience of min 8 years in the pharmaceutical and/or biotech industry preferably in Quality related roles and in market readiness activities
Thorough knowledge in cGMP and GDP and global regulatory requirements
Qualified auditor with proven experience in GMP/GDP audits is a plus
Strong interpersonal skills
Excellent verbal and written communication skills
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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