Senior Quality Assurance Scientist
To assure that the manufacturing operations (Parenteral and/ or
Oral Solid Dosage) are performed in compliance with domestic and
international cGMP regulations, and policies and procedures. To
provide scientific approach and Quality assurance direction to the
approval of the GMP documents such as batch records, protocols,
procedures, qualification and validation reports. Enforce critical
analytical thinking in the investigation management process
specifically during root cause analysis, risk assessment evaluation
and corrective and preventive actions determination to guarantee
that gaps are properly addressed. Interfaces directly with
manufacturing operations to ensure that appropriate procedures are
in place, through the execution of thorough reviews of procedures
against practice. Leads and participates in the critical review of
all documents associated with the manufacturing operations,
release, packaging and relevant activities in the operations areas.
Ensures that deviation on documentation dealing with OOS or process
parameters outside filing or validation are investigated and
resolved by thoroughly reviewing timely corrective actions.
Provides key technical guidance and oversight to manufacturing
operations areas (OSD and / or Parenteral product) such as
Compounding, Filling, preparation, capping, Inspection, compression
and packaging to assure the appropriate cGMPs are in place through
weekly operations audits. Ensures compliance of all procedures
(SOP's) to avoid potential regulatory and compliance issues.
Provides scientific input into investigations management to assure
root cause and CAPAs are aligned with the opportunities identified
in order to perform a systematic approach. Supports actively the
investigation process occurred in manufacturing area (OSD and
Parenteral products) and warehouse, Microbiology laboratory,
facilities and utilities providing coaching from Quality
perspective. Manages audit observation, investigations, change
control and CAPAs records in Trackwise on timely manner. Provides
technical guidance and quality assurance support in the transfer of
new products and process to maintain quality standards.
Bachelor Degree in Science (Chemical, Engineering, Biology,
Pharmacy or Microbiology). Six (6) years of experience in Quality
Assurance responsibilities in a pharmaceutical industry.
Knowledge of manufacturing operations of Oral Solid Dosage and
Parenteral Products Manufacturing Fully bilingual (Spanish/English)
communication skills, both written and verbal. Proficient knowledge
of computer systems (Microsoft Office etc.) and applications like
Trackwise and SAP. Solid ability for analyzing data detecting
deviations, inconsistencies and interpret sampling test results.
Proficient knowledge of problem solving and root cause analysis
methodologies (i.e. Kepner Tregoe)
*Willing to work irregular hours, rotative shifts, weekends
and holidays when needed.
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