Job description

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Role Summary

The Sr. Quality Assurance Specialist will be responsible for activities related to vendor qualification as well as internal audit quality processes to ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.This role will act as the primary liaison between the company and its suppliers on all quality-related matters, ensure that internal audit operations meet the highest standards of quality and compliance, support all Engineering Facilities initiatives, and report to the QA Lead – Engineering Facilities Support.

Essential Duties and Responsibilities

Vendor Quality Management

• Follow LRI’s procedures applicable to vendor management and internal audit process.
• Support the development, implementation, and maintaining of the Vendor Quality Managementprogram.
• Conduct risk assessments of new and existing vendors and contractors.
• Support vendor qualification including qualification and periodic vendor audits.
• Manage vendor change notifications and assess impact on product quality.
• Partner with procurement and technical teams to resolve vendor quality issues.
• Maintain and monitor vendor performance metrics, KPIs, and scorecards.

Internal Quality Audit

• Support internal quality audit systems, including deviation
• Review of tests results generated in support of environmental monitoring (EM) (viable and non-viable).
• Initiate QE for EM results not meeting acceptance criteria. Perform trend analysis and generate trend reports.
• Review of Quality events, incidents and deviations related to the facility, equipment and engineering and their impact on manufacturing processes/operations and laboratory operations.
• Keep track of data and records review indicators from engineering and facilities for internal quality metrics and annual product review as appropriate. management, CAPA, change control, and document control.
• Support and coordinate internal audits to assess compliance with SOPs, cGMP, and regulatory requirements.
• Support external regulatory inspections and customer audits.
• Review and approve quality-related documents, including SOPs, batch records, and validation protocols.
• Ensure timely closure of deviations, investigations, and CAPAs.
• Drive continuous improvement initiatives to enhance internal quality systems and processes.

Engineering Facilities Support

• Review of engineering documentation, protocols, records, and other related materials—both pre- and post-execution—pertaining to Engineering, EHS, and Facilities.
• Review equipment qualification/calibration/validation documents and computer system validation packages.
• Review all pest control documentation.

Qualification and Experience

• A bachelor’s degree (B.S.) in Chemistry, Biology, Microbiology, Pharmacy or Engineering related field.
• Over 5 years of Quality Assurance experience in an FDA-regulated Pharmaceutical/Medical Device manufacturing environment with at least 3 years’ experience in vendor quality management, internal quality audit, and/or engineering facilities support.
• Strong understanding of cGMP, ICH guidelines, FDA, EMA, and other global regulatory requirements.
• Strong interpersonal, communication, and negotiation skills.
• Understanding of SOPs, validation/qualification concepts, HVAC, water systems, ALCOA and data integrity procedures, guidelines and requirements.
• Demonstrate computer literacy with proficiency in Microsoft office software and electronic quality management systems (eQMS).
• Strong organizational skills desired. · Strong oral and written communication skills, including effective listening.
• Must possess excellent oral and written skills in the English language.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements The physical requirements of the position generally include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in an office environment.

Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility