Quality Assistant

Role - Quality Assistant Location – Kinsale Onsite, Kinsale Cork Contract type - Permanent Work model – Onsite Working hours - 8:30 - 16:00 At Covalen, we're not just a business process outsourcing (BPO) service provider – we're industry pioneers collaborating with organizations worldwide for over 25 years. From established sectors to cutting-edge industries, our tailored BPO solutions forge powerful partnerships, helping clients achieve their unique goals. Main Purpose and Objectives of Position:

1. Provide key support to the QA function within Stability Management, Material Management/Supply Chain and QA support.
2. Co-ordination of the Stability Program- Management including study activations, study sample inventory, equipment monitoring, manage stability samples, approval Stability Study Reports.
3. Responsible for the Packaging/preparation of the Product in the Laboratory.
4. Responsible for quality-related matters specific to area of responsibility, including any Deviations and associated Investigations.
5. Generation of Certificates of Analysis/Conformance to support shipping requirements.
6. QA review of laboratory notebooks and logs.
7. Assist with reconciliation of laboratory notebooks as required.
8. Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
9. Provide backup for specific QA Assistant activities as required.
10. Work effectively within the QA function to deliver on objectives.

Key Responsibilities:

1. Site stability program co-ordination.
2. Working with the Annual Stability Sampling Plans ensuring oversight stability sample management.
3. Participating member of a New Product Introduction team of the product’s stability requirements.
4. Study management for Stability program lots, study timepoint pulls, completion of Stability Studies.
5. Development of Study Lot Details and creation of Graphics on Darwin Stability Program.
6. Study completion and notification to management for final approval.
7. Monitoring stability units – alarm response, review of temperature/humidity trends.
8. Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping.
9. Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained.
10. Perform COA compliance checks for Consumables and raw materials.

Requirements:

1. Education: Hons BSc, MSc, Chemistry, Engineering, Quality, or related discipline, with a minimum of 2 years relevant experience.
2. Excellent communication skills in English.
3. System experience is an advantage: Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.

What would you bring? As a valued team member, you'll play a crucial role in delivering customized BPO solutions, ensuring our clients achieve consistent high performance and meet their strategic objectives. Equal opportunity employer: At Covalen, we champion diversity and equality, anchoring our workplace cultures and creative minds. For more information, don't hesitate to reach out to alessandra.fenu@covalensolutions.com , your journey to becoming a valued part of Covalen starts here. Apply Now or Reach Out for More Information. #J-18808-Ljbffr