Executive - Gdp Compliance

**Date**:7 Feb 2025

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

**Company**:AdvanzPharma
- Job Title: GDP Compliance Executive
Department: Quality (Mumbai)
- Grade: P1
- Location: Mumbai
Reports to: Manager - GDP Compliance
Main purpose of role:
To ensure the organization abides by the guidelines on Good Distribution Practice (GDP) according to the Quality Management System (QMS) in place, in line with the EU Guidelines on Good Distribution Practice Medicinal Products for Human Use (2013/C 343/01) and local market regulations.
Key responsibilities (In Points):
All distribution activities are in line with the relevant process licenses held within the organisation

Direct communication with all third party distributors and business partners

Lead the investigation and closure of deviations related to GDP activities e.g. Temperature excursion deviations

Management and maintenance of system for bona fide checks for suppliers, direct customers and third party distributors

Maintenance of all official Authorisations registered with ADVANZ PHARMA group.

Maintenance of Competent Authorities inspection schedule, preparations and post inspection follow up

Effective communication with the Quality and cross functional teams

Participation to the GDP team projects.
KEY ACCOUNTABILITIES:
To document and verify the global transportation routes taken for all products, working closely with the Supply Chain department and external contractors.

To assess the temperature monitoring / control requirements for each transportation route.

Periodic review of validated transport routes to ensure compliance and adherence.

Build and maintain a strong and co-operative relationship with the competent authorities enhancing Company’s reputation over time

To ensuring that an effective QMS is implemented and maintained

To coordinate the supply of Controlled Drugs inventory information to the Home Office.

To assist in the coordination and execution of any recall operations of medicinal product in accordance with ADVANZ PHARMA procedures.

To assist in that GDP relevant customer complaints are dealt with effectively in accordance with Company’s procedures.
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To assist in supporting project/integration activities

To support maintenance of Company’s official authorisations including but not limited to Wholesalers Dealers Authorisation, Manufacturer and Importers Authorisation (or equivalent as per local regulations), Active Substance Registration and Controlled drugs licenses

To implement new and updated official authorisation through change control system.

To organise periodic official Authorisation Review meetings

To ensure that adequate and complete records relating to GDP are maintained

To assist in that all personnel are trained to carry out their respective duties in relation to GDP

To ensure contracts are in place between Company and Contract Acceptors relating to distribution activities.

To employ due diligence in the discharge of duties and to report to senior management and the relevant EU authority of any awareness of suspicious events or falsified products.

To maintain competent authorities inspection schedule, coordinate preparation and track post inspection follow up actions

To assist during an inspection by the competent authorities

To keep up to date with current regulations and industry standards through a program of continuous professional development

To acquire and keep up to date of GDP regulations and guidance in the assigned territories

To take part in the continuous improvement projects as assigned

To cross training among the team for holiday and absence cover