02 Oct
|
Sun Pharmaceutical
|
India
02 Oct
Sun Pharmaceutical
India
Job Title:
EU Compliance Specialist
Business Unit:
Global Quality and Compliance
Job Grade
Manager-1
Location :
Paonta Sahib/
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a cooperative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
The EU Compliance Specialist will be responsible for supporting EU-related activities in the Sun India DF site which manufacture products for the EU and UK markets. Documents related to EU-products such as (but not limited to) Change Controls (including Temporary CC’s), Market Complaints, Investigations associated with Deviations,
OOS/OOT shall be screened for robustness prior to sharing with the EU QP teams. Supporting site compliance to EU-GMP Guidelines and their implementation, in addition to supporting ad-hoc requests from the EU Compliance Lead and/or EU QP and Compliance teams will be required.
Major Tasks & Responsibilities:
- Assess all site investigation related to EU-products for completeness and robustness
- Liaise with the EU Compliance Lead on all matters of concern related to EU GMP’s and EU-products.
- Triage investigations at site related to EU products and confirm accuracy of classification by site.
- Ensure all Change Controls with major or critical impact (impact to either product process validation status or marketing Authorisation) are shared for pre-approval by the EU QP’s.
- Maintain open and effective communication channels between India Sites (EU supplying) and EU Compliance Lead so that information flowing to EU QP’s is accurate.
- Ensure regular communicati
📌 Manager- EU Compliance (India)
🏢 Sun Pharmaceutical
📍 India