Manager- EU Compliance (Paonta Sahib)

Manager- EU Compliance (Paonta Sahib)

11 Sep
|
Sun Pharmaceutical Industries
|
Paonta Sahib

11 Sep

Sun Pharmaceutical Industries

Paonta Sahib

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 communication cadence wi

📌 Manager- EU Compliance (Paonta Sahib)
🏢 Sun Pharmaceutical Industries
📍 Paonta Sahib

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