Gmp Auditor-pharma

5 months ago

Viman Nagar Pune Maharashtra, India Pharma Jobs India Full time

**GMP Auditor (Pharmaceutical Quality)**

**LEAD AUDITOR-GMP** (for **Pharmaceutical Formulations** Exporting European Company)
- **(Only those who are GMP Quality Auditors with pharmaceutical formulations companies need apply).**_

Someone who has experience in a multinational company and has been exposed to UK/EU and FDA audits at least as an auditee. We might find people who specialize in Laboratory/Analytical (than Production) would be more suitable. Also experience with Sterile and Non-Sterile would be relevant.
- Managing the audit program
- Leading audits (GMP, qualification of new suppliers, for-cause etc)
- Ensuring that high quality, relevant, reports and generated in a timely manner and closely followed up with the site to ensure CAPAs implemented
- Leading the engagement of third party auditors in remote geographies if needed e.g. Canada etc
- Managing and mentoring direct report(s) in Pune and guiding audit activities needed in Australia & other countries if other staff here participate e.g warehouses

The Lead Auditor will work collaboratively with the Operations team, Scientific Affairs team and stakeholders to define and deliver quality and compliance plans and objectives. This is to ensure the products supplied to our customers meet the relevant regulatory standards, contractual obligations, and our internal quality standards.

The Lead Auditor manages and delivers Company's Supplier Audit program to ensure Company's quality and compliance standards are communicated and maintained. Responsibililties include managing the audit program and auditing staff; performing routine GMP, for-cause and due-diligence audits of current and potential suppliers/manufacturers; delivering audit reports; ensuring CAPAs are addressed and closed in a timely manner; and maintaining the audit system and metrics.

The Lead Auditor will ensure that all activities are completed with the highest level of care and accuracy, and in a timely manner to maintain continuity of supply. In addition, the role will focus on continuously improving our compliance stature by ensuring our suppliers meet regulatory requirements and Company's quality expectations.

**ACCOUNTABILITIES AND RESPONSIBILITIES**

**Accountability Area % of Role**

**Key Activities and Responsibilities**

Supplier Audit and Qualification Program

65%
- Manage the Supplier Audit program including audit scheduling, reporting, follow up on CAPAs and generation of associated metrics
- Collaborate with internal stakeholders to understand the business needs and context driving the Audit and Qualification program
- Schedule and perform supplier audits as Lead Auditor
- Perform GMP audits to assess and assure existing supplier compliance profiles.
- Perform due diligence audits to assess the quality and compliance risk profile for new suppliers and contract manufacturers.
- Perform for-cause audits to investigate and assess the risk posed by suppliers that have reported significant, repetitive deviations or quality issues, or suppliers that have had adverse regulatory authority findings made against them.
- Deliver reports of appropriate accuracy, detail and quality dependent on type and findings of audit, Reports should be precise, concise, and delivered in a timely manner.
- Ensure appropriate assessment of issues, and timely execution, closure and effectiveness of CAPAs in response to supplier audit findings such that suppliers maintain compliance to Company's quality standards.
- Develops and directs Auditors including direct report(s), staff supporting audits from other Company's offices
- Advises on and leads the engagement of third party auditors when required to cover remote geographies.

Quality management system, governance and metrics

20%
- Develop policies, procedures, systems and metrics in relation to supplier audits.
- Maintain and continuously improve processes and procedures to ensure efficient and compliant ways of working.

Quality Risk Management

10%
- Collaborate with stakeholders to prioritise audit schedule and audit focus based on
- business context such as volume, significance to the portfolio
- supplier and product quality and compliance history such
- Assign and maintain supplier risk ratings matrix

Health, Safety and Wellbeing / General

5%
- Adhere to the Company's Health, Safety and Wellbeing policy, procedures and systems.
- Maintain a clean and orderly workplace.
- Take reasonable care for own and others health and safety.
- Participate in health and safety training.
- Identify hazards and incidents in the workplace and if not immediately controllable, report and inform hazards and incidents in accordance with policy to relevant persons and management.
- Champion Company's Mission, Aims, Objectives and Values.
- Work cooperatively with colleagues across the Company.
- Actively participate in opportunities to communicate within Company's including attending team meetings.
- Demonstrate a willingness to work flexibly with others to

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