QA Associate

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Scope of Position**:
Product complaints processing and management, batch disposition and QA related activities.

**Objective**:
Responsible for product complaints management process, documentation and metric management.

Ensure product complaints including counterfeit cases are reported, processed and customer response (where applicable) are provided within the required timeframe.

Manage timely release of finished products for distribution in compliance with Lilly quality standards and local ANZ regulations.

Act as PQR back-up whenever it is needed.

**Technical training, personal skills and experience required**:
1. University degree in Pharmacy/Life Science or equivalent valid in the corresponding country

2. Minimum one year experience in the area of quality in the pharmaceutical or related industries.

3. Knowledge and mastery of basic computing tools (Microsoft Office) and preferably Trackwise

4. Leadership ability to relate to others and achieve results

5. Ability to train working groups for AE/PC courses

6. Effective communication in written and oral

7. Problem solving and interpersonal skills.

8. Negotiation and time management skills.

9. Ability to prioritize, agile and sense of urgency

10. Understanding of pharmaceutical industry regulations

**The Quality Assurance Associate/RCP is responsible for**:
1. **Implementation of product complaint process in accordance with applicable GQS /LQS 130 Product Complaints)**

1.1 Establish and implement local complaint procedure

1.1.1 Maintain the local procedure for product complaint including the

required elements in applicable GQS/LQS and local regulation

1.1.2 Provide product complaint training

1.2 Responsible Complaint Person is responsible for managing:
1.2.1 Collection of product complaints including counterfeit complaints

1.2.2 Documentation of product complaints in the global product complaint database (Trackwise)

1.2.3 Complaint sample handling including retrieval from reporters and shipping to regional centre for investigation

1.2.4 Appropriate notification to management and to other affected areas or sites where required

1.2.5 Provision of response letters to reporters where required and complaint closure within 45 calendar days from notification date

1.2.8 Ensure complaint management, roles and responsibilities are defined in a written agreement for collaborations with external parties

1.2.9 Perform monthly and quarterly analysis of complaint as per AP metric reporting cycle time

1.2.10 Provide product complaint trend analysis on a regular basis and identify potential areas of improvement to reduce product complaints.

1.2.11. Escalation of product quality issues that may result in potential recall

1.2.11 Interaction with local regulatory authorities TGA/Medsafe as per LQS112 where required

**2. Release for Distribution (batch release)**

2.1 Review and release finished products prior to distribution

2.2 Liaise with local, global cross functional teams and external service partners in relation to documentation and inspection required for batch release

2.3 Manage product release in SAP

2.4 Raise internal distribution complaints with the shipping sites where required

**3. Assist and ack as PQR back-up for implementing the Quality Manual for Marketing Affiliates (CQP-181-1) and initiatives at local level**

3.1 Assessment and disposition of products due to temperature excursion

3.2 Raise change controls and deviations in Trackwise

3.3 Review deviations from external service partners

3.4 Support PQR with other quality related activities and projects that will be delegated from time to time.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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