QA QMS Specialist
QA QMS Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The QA QMS Specialist is responsible for executing and maintaining Quality Management System (QMS) processes with a strong focus on deviation investigations CAPA root cause analysis and QMS compliance in a cGMP pharmaceutical environment. The role supports cross-functional teams and ensures documentation quality and regulatory standards are met consistently.
Key Responsibilities-
Conduct investigations for OOS OOT Deviations and customer complaints.
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Perform root cause analysis using tools like 5-Whys fishbone diagrams etc.
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Develop implement and track CAPAs to prevent recurrence of issues.
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Collaborate with cross-functional teams to gather data and implement QMS actions.
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Maintain detailed and accurate documentation related to investigations and CAPAs.
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Prepare reports and summaries for management review.
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Support regulatory inspections and internal audits.
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Stay current with applicable industry regulations and internal quality standards.
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Perform additional duties as assigned by management.
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Bachelors degree in Science Pharmacy or a related field.
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3 5 years of experience in pharmaceutical manufacturing with a focus on Quality/QMS roles.
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Strong knowledge of cGMP GDP and regulatory standards (e.g. ICH USP CDER).
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Proficiency with QMS software (e.g. TrackWise).
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Technical writing skills for QMS documentation.
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Strong analytical organizational and communication skills.
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Ability to work independently and in cross-functional teams.
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Proficiency in Microsoft Word Excel and PowerPoint.
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Flexibility to work across different shifts as per business needs
Employment Type
Full-time
