Executive - Batch Compliance

1 week ago

Andheri East Mumbai Maharashtra, India Advanz Pharma Full time

**Date**:23 Feb 2024

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

**Company**:AdvanzPharma

**Main purpose of role**:

- To ensure batches are released in accordance with defined procedures and within appropriate timeframes to support business need.

**Key responsibilities (In Points)**:

- To perform accurate and timely review of various batch documents and confirm that the batch meets the relevant standards before being placed on the market
- To liaise with the Supply Chain Management team in support of the assessment of batch/manufacturer information and business priorities.
- To ensure that the relevant database is update with every batch released
- To report any out of specification or out of trend result and assist the deviation team during investigation.
- To improve the overall cycle time on batch release.
- To review batch documents and confirm that the batch meets the relevant regulatory standard. Only those batches are released to market for sale.
- To assess the performance of every manufacturer and prepare a risk assessment report determining the level of detailed information required during batch release
- To ensure that the batch release and other associated SOPs are thoroughly followed and suggest improvement
- To ensure products are blocked/ unblocked as per request from GxP teams and relevant database is update with every action.

**Job: Executive Batch Compliance**

**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
- Artworks Implementation.**What You’ll Do**:

- To perform accurate and timely review of various batch documents and confirm that the batch meets the relevant standards before being placed on the market
- To liaise with the Supply Chain Management team in support of the assessment of batch/manufacturer information and business priorities.
- To ensure that the relevant database is update with every batch released
- To report any out of specification or out of trend result and assist the deviation team during investigation.
- To improve the overall cycle time on batch release.
- To review batch documents and confirm that the batch meets the relevant regulatory standard. Only those batches are released to market for sale.
- To assess the performance of every manufacturer and prepare a risk assessment report determining the level of detailed information required during batch release.
- To ensure that the batch release and other associated SOPs are thoroughly followed and suggest improvement.
- To ensure products are blocked/ unblocked as per request from GxP teams and relevant database is update with every action.

**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**:

- Must have significant experience in reviewing the batch documents.
- Graduate with science background with specialisation in Chemistry/Biology/Pharmacy (or close equivalent) or a post-graduate in relevant field.

**Knowledge, Skills & Experience**:

- Hands on experience on various laboratory instruments like HPLC, GC in a reputed pharmaceutical company.
- Has experience of working in a virtual company environment.
- Excellent interpersonal, communication, organizational skills, and attention to detail.
- Knowledge of European Regulations, Guidelines for pharmaceutical products.
- A positive and ‘can-do’ approach, biased t

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