Manager Quality Assurance

3-5 years

Not Disclosed

Mumbai

10 Dec. 30, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Supplier Quality Auditor

Primary Objective:

To conduct audits of raw and packaging materials vendors, third-party manufacturers, and contract testing laboratories to ensure compliance with Abbott’s quality standards and regulatory requirements. The role also involves planning and conducting internal audits, monitoring CAPA implementation, and supporting supplier development and performance monitoring.

Core Job Responsibilities:

Vendor Audits:
- Conduct audits of raw and packaging material vendors, including active material and excipient vendors for Abbott EPD India and other regions as required.
- Perform audits of third-party manufacturers for finished products and contract testing laboratories that supply products and services to Abbott EPD India.
Internal Audits:
- Plan and conduct internal audits for Abbott EPD India to ensure compliance with corporate standards and regulatory requirements.
- Review and periodically update Supplier Management procedures in line with corporate procedures (AQ, EQD, EID).
Audit Scheduling & Tracking:
- Prepare and manage audit schedules, ensuring accurate tracking and adherence to the annual audit plan.
- Monitor the implementation of corrective actions (CAPAs) related to audit findings, ensuring timely completion and documentation in the AudiQ system within Trackwise.
Alternate Vendor Development:
- Participate in alternate vendor development projects, supporting the evaluation and selection of new suppliers as required.
Due-Diligence & For Cause Audits:
- Conduct due diligence audits of potential new contract manufacturing sites to assess quality systems and compliance.
- Perform “For Cause” audits in response to quality issues or significant events to investigate the root cause and ensure corrective actions are taken.
Supplier Performance Monitoring:
- Complete annual supplier performance monitoring, ensuring suppliers meet Abbott’s quality standards.
- Perform supplier risk assessments after caution audit outcomes or high-risk events to ensure ongoing compliance.
Investigations & CAPAs:
- Address supplier complaints and quality issues by supporting and coordinating investigations, ensuring appropriate CAPAs are implemented.
Audit Readiness Support:
- Provide support to in-house Abbott facilities in EPD India, ensuring readiness for corporate and regulatory audits.
Collaboration & Stakeholder Management:
- Collaborate with key stakeholders within the organization to facilitate smooth business processes related to supplier quality and compliance.
Review Documentation:
- Review Quality and Technical Pack documents for new and alternate vendors to ensure compliance with Abbott's standards.
Approved Supplier List Maintenance:
- Support in the preparation, updating, and maintenance of the Approved Supplier List to ensure accurate and up-to-date supplier information.

Key Skills and Competencies:

Audit and Compliance Expertise:
- In-depth knowledge of auditing procedures, including for raw materials, packaging, and contract manufacturers.
- Experience in conducting due diligence and “For Cause” audits to investigate quality issues and ensure compliance with industry standards.
Corrective Action Management (CAPA):
- Proven ability to track and manage the implementation of CAPA from audit findings, ensuring timely resolution and documentation.
Vendor and Supplier Management:
- Strong understanding of supplier performance monitoring, including risk assessments and the ability to support alternative vendor development.
Collaboration and Communication:
- Excellent communication and interpersonal skills to collaborate with internal teams and external suppliers, ensuring adherence to Abbott's quality standards.
Documentation and Reporting:
- Ability to review and assess quality and technical documents, ensuring compliance with company standards and regulatory requirements.
Audit System Proficiency:
- Experience using systems like AudiQ and Trackwise for CAPA management and audit tracking.

Qualifications:

Education:
- Bachelor's or Master’s degree in a relevant field such as Chemistry, Life Sciences, or Quality Management.
Experience:
- 3-5 years of experience in supplier quality auditing, vendor management, or quality assurance in a regulated industry (pharmaceuticals, food, or medical devices).

This role ensures that all suppliers meet Abbott's quality expectations through regular audits, thorough investigations, and close collaboration with key stakeholders. It is essential for ensuring the ongoing compliance of Abbott’s supply chain with internal and external standards.

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Manager Quality Assurance

Job Description

Job Title: Supplier Quality Auditor

Primary Objective:

Core Job Responsibilities:

Key Skills and Competencies:

Qualifications:

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