Supplier Quality Auditor

Gsk Plc

3+ years

Not Disclosed

India Mumbai

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Role: Supplier Quality Assurance (SQ A&C) - GSK

Location: India - Maharashtra - Worli Mumbai
Posted Date: Jan 27, 2025

Job Purpose:

The purpose of this role is to ensure that material and service suppliers within the scope of SQ A&C meet applicable GSK and regulatory requirements. This includes the execution of assessments, management of supplier CAPA plans, and effective interfacing with the supply base to manage supplier issues.

Key Responsibilities:

Supplier Assessment, Approval & Compliance:

Perform Quality System assessments/audits of assigned suppliers to determine GMP approval status and document the findings in relevant systems within targeted timelines.
Agree on appropriate corrective and preventive action (CAPA) plans with suppliers and follow up to ensure completion within the agreed timelines.
Ensure that all audit-related documentation is communicated within targeted timelines, and CAPA documents are reviewed and responded to promptly.
Conduct For Cause/Target audits to support supplier complaints and changes due to significant quality incidents.
Maintain auditee profiles (supplier data) and keep records up to date with relevant information.
Support actions associated with supplier change controls/change notifications and ensure the completion of Quality Assurance Agreements (QAAs).
Lead/support third-party audits conducted by auditing firms or contract auditors to ensure compliance with GSK processes.

Risk Management:

Identify and escalate high-risk issues to ensure stakeholders understand technical, regulatory, and quality risks and identify mitigating actions.

Regulatory / Customer Inspection Support:

Provide relevant support to GSK sites during regulatory/customer inspections as assigned.

Internal Supplier Quality Processes:

Participate in the development and implementation of internal Supplier Quality processes to ensure compliance with the GSK Quality Management System (QMS).
Complete all relevant training curriculums in a timely manner and remain updated with technical processes and industry trends.

Interfaces:

Regularly interface with site Quality/Procurement, Procurement Commodity teams, SQ Ops/QSIM, and GSK suppliers to communicate audit results, CAPA plans, and any issues impacting materials, components, and services delivered to GSK sites.

Educational Background:

Minimum Level of Education:
- A Science degree and at least 3 years of relevant experience in Pharmaceutical/BioPharma/Vaccines manufacturing, quality operations, and/or supplier quality management.
Preferred Level of Education:
- A Graduate degree in Biology, Chemistry, Pharmacy, Food/Chemical/Biotechnology, or an equivalent Engineering discipline.

Why This Education is Required:

To understand regulations, standards, and production processes of materials sourced by GSK and make risk-based decisions regarding supplier approval.

Experience Requirements:

Proficiency in planning and executing audits to identify and reduce significant risks/non-compliance.
Knowledge of GMP and GSK quality requirements and ability to apply these to both GSK and supplier operations.
Ability to influence and negotiate with suppliers and internal stakeholders.
Good verbal and written communication skills to ensure clarity in the relay of issues, risks, and action plans.
Experience with Microsoft Office and the ability to learn and apply new software tools (e.g., audit management software, virtual meeting tools).

Other Skills and Background:

Travel Requirements: Ability and availability to travel (locally, domestically, and internationally) to suppliers as needed for assessments.
Time Management: Strong ability to meet deadlines and complete tasks within required timelines.
Matrix Organization Skills: Ability to work effectively across multiple cultural and geographical boundaries.
Certification: Nationally recognized auditor certification or GSK Certified Auditor status preferred.

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