Executive, Audit

3 weeks ago

Andheri East Mumbai Maharashtra, India Advanz Pharma Full time

**Date**:10 Apr 2024

**Location**: Andheri (East), IN, Mumbai 400

**Company**:AdvanzPharma

**Job Title: Audit Executive**

**Location: Mumbai**

**About ADVANZ PHARMA**
- ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.- Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.- Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.- ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.- We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.**About the Role**
- As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Audit Executive to join our Global Centre of Excellence in Mumbai.- The Audit Executive will support the Quality Audit Team for maintaining the qualified status of contract manufacturing organisations in accordance with the appropriate industry regulations and guidelines.**What You’ll Do**:

- Will work cross-functionally with Supply Chain, Regulatory, Operational Projects, New Product Introduction and Quality colleagues to ensure tracking of audit and qualification activities are aligned to business requirements.
- Have responsibility for the planning of external Quality audits based on the annual audit schedule and business requirements.
- Create annual audit schedule and audit program in Vault QMS for third party finished product suppliers, manufacturers of active substances used in Advanz Pharma’s products, agents, distributors, contract testing laboratories and other GxP suppliers (excluding Pharmacovigilance suppliers/partners)
- Co-ordinate with suppliers for on-site audit dates and co-ordinate within the audit team
- Assist the audit team with pre audit activities i.e. pre-audit checklist, coordinate the audit questionnaire, audit agenda, visa requirements etc
- Co-ordinate with corrective and preventive action plans (CAPA) for both internal and external suppliers
- Ensure timely implementation of actions derived from Advanz Quality Management Systems assigned to the audit team i.e. deviations, CAPAs etc
- Monitoring and tracking to ensure audits are performed within the due dates and support with unqualified risk assessments to maintain supply continuity
- Maintain vendor validity in the ERP (SAP) system
- Coordinate with purchasing of 3rd party audit reports and subsequent activities i.e. raising purchase orders, availability of reports, addressing queries, follow up on payment etc
- Co-ordinate adhoc requests received from internal and external customers
- Maintain audit qualification in internal systems i.e. SAP, Vault QMS, VML, Audit schedule
- Assist with the preparation of metrics arising from Quality audits and provide within required timelines
- Assist with the preparation of audit related activities to support internal and external audits
- Other activities as may be required at the discretion of the Senior Quality Manager - Quality Supplier Assurance
- Thrive in an entrepreneurial environment, and take accountability for results.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.

**About You**
- We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.- For this role, you will also have the following:
**Qualifications**:

- Ideally be a Graduate in Chemistry, Pharmacy or Microbiology or equivalent discipline, and hold a General Auditing Qualification

**Knowledge, Skills & Experience**:

- Fluent in written and spoken English
- Experience of working within a Pharmaceutical company and understanding of Quality Management System processes
- Capable of working to deadlines, with

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