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. We've built enduring relationships in Financial Services, Technology, and Utilities, working with some of the globe's largest and most forward-thinking companies.
Main Purpose and Objectives of Position:
· Provide key support to the QA function within Stability Management, Material Management/Supply Chain and QA support.
· Co-ordination of the Stability Program- Management including study activations, study sample inventory, equipment monitoring, manage stability samples, approval Stability Study Reports.
· Responsible for the Packaging /preparation of the Product in the Laboratory.
· Responsible for quality-related matters specific to area of responsibility, including any Deviations and associated Investigations
· Generation of Certificates of Analysis/ Conformance to support shipping requirements.
· QA review of laboratory notebooks and logs.
· Assist with reconciliation of laboratory notebooks as required.
· 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.
· Provide back up for specific QA Assistant activities as required
· Work effectively within the QA function to deliver on objectives
Key Responsibilities:
· Site stability program co-ordination.
· Working with the Annual Stability Sampling Plans ensuring oversight stability sample management.
· Participating member of a New Product Introduction team of the product’s stability requirements, e.g., stability cabinet/storage capacity, stability simulator, stability specification and time-point requirements.
· Study management for Stability program lots, study timepoint pulls, completion of Stability Studies. Flag the batch, Register the Parent lot and complete Study Activation, Receiving Stability Parent Samples.
· Development of Study Lot Details and creation of Graphics on Darwin Stability Program.
· Study completion and notification to management for final approval
· monitoring stability units –alarm response, review of temperature/ humidity trends to ensure alarm response/ deviation are complete.
· Materials Management/Supply Chain
· Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping using various systems and reports, working with Shipping schedule.
· Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained
· 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, Track wise, 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. Your expertise will contribute to our legacy of success in providing outsourced solutions for Fortune 500 companies.
Ready to be a part of our dynamic team? Explore exciting opportunities with Covalen – where your skills, ideas, and achievements are celebrated!
Equal opportunity employer:
At Covalen, we champion diversity and equality, anchoring our workplace cultures and creative minds. We recognize the collective strength found in the diverse backgrounds, skills, and experiences of our team members. Our commitment to fostering an inclusive environment transcends gender, marital status, family status, age, disability, sexual orientation, race, religion, and membership in the Travelling community.
For more information, don't hesitate to reach out [email protected], your journey to becoming a valued part of Covalen starts here.
Apply Now or Reach Out for More Information.
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