Frankfurt am Main, Germany
100,000 € +
6 months ago
Do you want to be a part of something unique, rare and innovative? Do you see yourself being at the forefront of new sciences and technologies?
A family run, global pharmaceutical company since it was established over 130 years ago are looking for a Quality Assurance Director to join their growing team; to be based at their site in Germany. This organization focus on improving the health and quality of life of patients. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives.
In addition to the great internal culture and amazing opportunities, the company also has an outstanding global reputation. One of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, they achieved net sales of almost 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.
Don’t miss out on joining this organic journey!
Main duties include:
- Assure, direct and manage first time right quality performance of all operations, products and processes
- Establish common Quality systems across the Pharma business to assure Quality expectations within customers are met or exceeded
- Verify compliance with all certified internal and external standards (e.g. ISO 9001, 15378, 13485 cGMP etc.) and assure re-certification of given standards for all products and sites producing pharmaceutical film
- Manage global customer Quality Assurance agreements to define CTQ and responsibilities of both parties
- Support/lead cross functional teams to resolve customer complaints through a customer issue resolution, utilizing the Quality Improvement Process (QIP), A3s, 8D methods where appropriate, ensuring an effective corrective action and follow-up system
- Manage internal and external (including customer) audits and follow-up actions to ensure audit compliance
- Coordinate and monitor Continuous Improvement and Processes using FMEA / DOE / Six Sigma / HACCP studies for selected projects and processes and drive implementation of results
- Monitor and manage global and local change control processes to ensure sustainable product and service quality and proper change management and communication to customers
- Realize a risk evaluation process which enables the business to identify organizational, product safety or process.
Ideally you will bring:
- In-depth knowledge of Quality Standards used in the Pharma industry: ISO 9001, ISO 15378, ISO 13485, ISO 20000, ISO 18000, cGMP, BRC global, ISO 22000 etc.
- In-depth knowledge of Root Cause Analysis and improvement methodology: Six Sigma, 8-D, A3, 5-Why, Ishakawa, Pareto etc.
- Deep knowledge of the Pharma industry and its global regulatory framework (e.g. CFDA etc.)
- Knowledge of MOC / CC requirements for new equipment/upgrades and understanding of qualification requirements (DQ, IQ, OQ, PQ)
- Training and experience in Six Sigma Principles DMAIC
- Experience in leading deep-dive 8-D investigations into process improvements
- Experience in regulatory, standards compliance and customer audits
- Continuous Improvement experience in a pharma process environment
You can apply for this role by sending us your CV or by calling us now!
Specialist QA Recruiter
Contact: 0203 675 2956 or email email@example.com.
We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you.
You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.