Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more about Convatec, please visit .
Change is everywhere at Convatec. It’s transforming our business and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Quality Specialist and you’ll do the same!
The QA Specialist is an exciting role and will work closely with Operations and Supply Chain teams for QA related activities.
The QA aspects of the role will primarily involve timely approval of raw materials and intermediate products, management of non-conforming materials, environmental monitoring, GMP compliance, and support to validation and risk management activities as well as driving improvement of QA processes (e.g. via NC/CAPA/RCA).
Key Responsibilities:
* Ensures the timely approval of intermediate products as part of the batch release process as well as raw materials for manufacturing.
* Responsible for proper management (hold, decision making, release) of OOS raw materials and intermediate products in collaboration with Lab, Manufacturing, Supply Chain, and other relevant stakeholders including supplier for raw materials.
* Manages the routine material review board (MRB) including sending out status report (progress) and escalation to relevant stakeholders when required in collaboration with Supply Chain.
* Performs environmental control and monitoring sampling as per routine schedule e.g. cleanroom settle plates, Purified Water samples. Manages the results and coordinates/manages CA/PA as well as investigations against environmental monitoring issues.
* Conducts process, product, and GMP audits to verify compliance with critical GMP requirements. Provides status reports to relevant stakeholders as well as management of issues raised via NC/CAPA.
* Conducts GMP training during employee inductions and when necessary e.g. refresher.
* Drives improvement initiatives related to raw materials, intermediate products, GMP practices, environmental control & monitoring.
* Participates/supports generation of new and review of current process risk assessment e.g. pFMEA.
* Supports Validation execution and related activities e.g. OQ/PQ, NSPR.
* Works collaboratively with manufacturing to provide support, guidance, and coaching to assure compliance with internal QA procedures and instructions.
* Improves and drives performance of quality system processes in order to meet quality and site KPI’s.
* Supports compliance with and maintenance of quality system documentation in line with regulatory standards including ISO 13485, 21 CFR Part 820.
* Supports the internal quality audit schedule and executes the audits in accordance with the schedule. Produces clear and concise audit reports and enters non-conformances into the CAPA system.
* Provides cover for Quality Engineer or Quality Systems Engineer when necessary e.g. holidays.
Skills & Experience:
* Knowledge of ISO standards and FDA regulations.
* Successful participation in a quality system in a complex and regulated manufacturing environment.
* Experience with Change Control and Document Control in a regulated environment.
* Internal Quality Auditing for ISO 9001 / 13485 preferred.
* Competent in business standard systems e.g. SAP, eDMS, eQMS (NC, CAPA).
* Knowledge of Cleaning validation preferred.
* Excellent written skills which have been used to author both technical reports and quality documents (specification and procedural based).
* Six Sigma Green Belt qualification preferred.
* Use of Statistical software preferred.
* Process Validation (IQ, OQ, PQ, DoE) preferred.
* Competent in generation/principle of Risk Management (pFMEA) preferred.
Qualifications/Education:
* Educated to degree level or equivalent preferred.
* Understanding of GMP and Quality Systems in a Cleanroom Environment.
* Experience of regulatory standards including ISO 13485, 21 CFR Part 820.
Principal Contacts & Purpose of Contact:
* Internal – Manufacturing, Quality, Supply Chain, CI.
* External – Ad hoc contacts only e.g. bsi audit.
Travel Requirements:
Yes - Limited travel expected – Occasional audit support.
Languages:
* Speaking: English.
* Writing/Reading: English.
Working Conditions:
Based in the office environment with time spent on the manufacturing floor.
Our transformation will change your career. For good.
You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life.
There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll move you.
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