Executive - Quality Systems (Complaints)

4 days ago

Andheri East Mumbai Maharashtra, India Advanz Pharma Full time

**Date**:3 Jun 2024

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

**Company**:AdvanzPharma

**Location: Andheri, Mumbai**

**(Hybrid working opportunity)**

**About ADVANZ PHARMA**
- ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing 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 Executive
- Quality Systems.**What You’ll Do**:

- Execute Complaints investigations in accordance with the defined procedures ensuring that:

- Complaints are raised in the system.
- Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA).
- Complaint’s resolution is appropriately documented with supporting evidence.
- Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner.
- Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly.
- Follow up with CAPA owners to ensure that actions are implemented in a timely manner.
- To assist in executing Recalls as required.
- To assist in investigation of deviations when required.
- Creation of Quality related documentation (SOPs, Risk Assessments etc.)
- Carry out internal audits as required.
- Report Quality Systems metrics.
- Other activities as may be required, at the discretion of management.
- 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**:

- Minimum Honors Degree in Chemistry, Pharmacy or Microbiology.

**Knowledge, Skills & Experience**:

- Decent experience of working in a similar role within a pharmaceutical company.
- Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management.
- Knowledge of ICH Q9, ICH Q10 and Eudralex
- Volume 4 Good manufacturing practice (GMP) guidelines.
- Capable of working to deadlines & remain calm under pressure.
- Good working knowledge of MS Office.
- Well organised with logical & methodical approach to work.
- Excellent communication skills, both oral and written, to include senior management where escalation is required.
- A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
- Inspired by our values of entrepreneurship, speed and integrity.
- Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows.
- Work collaboratively across all business functions with an open, honest, and respectful cooperation.
- Ability to have fun and thrive in a growing, unique, and inclusive work environment.

**Why ADVANZ PHARMA?**
- The success of any company is driven by its people, and we are no different.- At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.- Our teams are made up of people from all walks of life and backgrounds. We

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