Customer Quality Excellence Engineer

Customer Quality Excellence Engineer

Victoria, Brasov

Ecolab, the world leader in resin-based separation, purification, and extraction technology, is seeking a Customer Quality Excellence Engineer at our state-of-the-art manufacturing site in Victoria, Brasov!

At Ecolab, we manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It’s an exciting business which helps make the world cleaner, safer and healthier.

This position is responsible for Quality Team support and ownership of customer focused activities. Working alongside the leadership in Quality, Supply Chain, Commercial, Sales, and Marketing teams, this role will deliver timely outcomes on customer deliverables such as, customer inquiries, customer audits, quality agreements, and customer complaints.

What’s in it For You:

• The opportunity to take on some of the world’s most meaningful challenges, helping customers achieve clean water, safe food, abundant energy, and healthy environments.
• The ability to make an impact and shape your career with a company that is passionate about growth.
• The support of an organization that believes it is vital to include and engage diverse people, perspectives, and ideas to achieve our best.

Why choose Ecolab?

• A world-leading international organization, benefitting from a diverse, multinational team.
• A fast-paced, dynamic, and rapidly growing environment
• Manufacture of high-quality technical products developed hand-in-hand with leading minds in the industry.
• Entrepreneurial workplace culture with a flat management structure, encouraging new approaches and ideas.

What you’ll do:

• Works closely with local and global quality team. Key point of contact for customer service.
• Supports and oversees customer audit process to ensure timely and thorough engagement from pre-audit notification all the way through CAPA & Effectiveness check completion.
• Supports and may coordinate team in GMP Inspections that are performed by the authorities and customers; prepare responses to the Inspections Reports, submits them for internal approval and submits approved responses to the authorities.
• Analyzes and approves general and operating procedures, work instructions and other quality-related documents developed in conformity with ISO 9001:2015, ICH Q7, FDA Guide – Title 21 parts 210 and 211, cGMP part II.
• Develops and maintains site quality metrics and ensures compliance in accordance with FDA requirements.
• Ensures that quality-related complaints are investigated and resolved as required.
• Reviews completed batch production and laboratory control records of critical process steps before release of the API’s, Excipients, and all other pharmaceutical products for distribution or prior to review during audits.
• Makes sure that critical deviations are investigated and resolved.
• Review and revise the regulatory documentation relevant for the pharmaceuticals.
• Ensures adherence to professional standards and ethics.
• Provides ad-hoc reports for senior management as required.
• Performs other duties as assigned.

What you'll need:

• Strong technical knowledge in pharmaceutical product laboratory techniques.
• Knowledge of quality assurance requirements: ISO 9001:2015 standard requirements.
• Knowledge of ISO 19011:2018 standard (the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process).
• Prior experience of dealing in EMA/ANMDM/FDA audits will be desirable.
• Has the ability to initiate tasks and work in an independent manner with follow-through.
• Proven analytical, evaluative, and problem-solving abilities.
• Excellent written and verbal communication and interpersonal skills.
• Must be able to effectively communicate with all levels and positions throughout the organization and with external contacts including regulatory authorities and agencies.
• Proven ability to support organization through quality audits.