Quality Assurance Specialist
Location: Hyderabad, India
Job Category: Quality Assurance
Job Type: Full-time
Req ID: QUALI002667
Job Overview:
The Quality Assurance (QA) Specialist is a hands-on, non-supervisory position supporting USP’s Quality Assurance team. This role is responsible for reviewing records for the qualification of reference standards and assisting in the USP Internal Audit programs. The QA Specialist will also investigate incidents and non-conformances, design and implement new tools and techniques for the Quality Systems at USP, and resolve problems within their area of responsibility.
Key Responsibilities:
Quality Systems:
Support the development, implementation, and monitoring of Quality programs, policies, and procedures to ensure compliance with certifications/accreditation requirements, corporate policies, and procedures.
Support the Supplier Quality Management program by conducting supplier evaluations, audits, and reviewing supplier performance metrics.
Review and approve equipment IQ/OQ/PQ documents, calibration documents, quality-related issues, complaints, deviations, investigations, and corrective/preventive actions.
Review and approve technical and analytical documents for Reference Standards and/or Analytical Reference Materials (ARM), method validation reports, batch records, and lab data projects.
Lead internal process audits, track and trend elements of the quality system, and report progress with areas of strength and opportunities for improvement.
Drive continuous improvement initiatives utilizing quality methodologies to optimize processes and enhance efficiency.
Participate in ISO 9001, ISO 17025, and other certification/accreditation activities.
Qualifications:
Education & Experience:
Master’s degree in a scientific field (Chemistry, Pharmacy, Biology) with experience in pharmaceutical or related industries.
Minimum 8-10 years of experience in Quality, including developing and implementing a Quality Management System.
At least 3 years of hands-on experience in laboratory activities, including handling analytical equipment, qualification, calibration, and metrology.
Experience with Analytical Method validations is an added advantage.
Must have experience with ISO 9001/17025 and/or GMP.
Skills:
Strong written and verbal communication skills.
Proficiency in conflict negotiation and resolution, with the ability to influence others at all levels.
Ability to prioritize tasks, multitask, and troubleshoot effectively.
Proficiency in MS Word, PowerPoint, and Excel.
Additional Desired Preferences:
Strong leadership skills in a dynamic business environment.
Ability to work independently and manage multiple tasks.
Demonstrated ability to identify and resolve quality non-conformance issues.
Ability to analyze data and trends, and use metrics to evaluate and implement solutions.
Benefits:
USP provides a comprehensive benefits package, including company-paid time off, healthcare options, and retirement savings, ensuring the well-being of employees and their families.
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