Executive - Gxp Documents

**Date**:17 Dec 2024

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

**Company**:AdvanzPharma

**Location: Andheri, Mumbai.**

**(Hybrid working)**

**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**
- The role will have a cross-departmental function to ensure effective management of documents within the Electronic Document Management System (EDMS). The role holder will also be responsible for GxP training compliance.

**What You’ll Do**:

- Ensures company's GxP training requirements are maintained by:

- Ensuring GMP training for new starters and refresher training is assigned for existing staff.
- Assigning relevant training for new starters
- Ensuring training curriculums are assessed for impact when new procedures are created/deleted/ or procedures are update.
- Ensuring training curriculums are updated/created to incorporate new starters or change in roles of existing staff.
- Ensuring training curriculums are in place for all GxP role.
- Supporting compilation, evaluation, and maintenance of training records and Reports.
- Ensures company procedures are reviewed in line with Quality defined requirements.
- Act as a document controller for procedure documents. (E.g., SOPs, WIs, Forms etc.)
- Support in update required to training & documentation procedures.
- Support any inspections, e.g., by regulatory bodies for training & documentation processes.
- Maintains and stores training documentation (e.g., training packages)
- Assists in departmental self-inspections and raise/close deviations/CAPA/Change controls on EDMS.
- Assists in archival of GXP documents at off-site document storage facilities and maintain records internally for area of responsibility, e.g., GMP training packages.
- 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**:

- Tertiary qualification in any discipline within Life sciences or Pharmacy.

**Knowledge, Skills & Experience**:

- Must have decent experience in GxP documents compliance & training in a highly regulated industry.
- Proven ability to handle electronic documentation and training systems.
- Open and adaptable to challenging environments.
- Must be quality oriented and willing to promote quality standards.
- Well-organized with logical and methodical approach to work.
- Ability to work with different Global culture and different time zones.
- Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others.
- 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