WHAT YOU WILL DO

Responsible for all quality control laboratory supervisors, leads, and technicians.Is accountable for all incoming, in-progress and final product testing.Monitors and communicates non-conformances to department supervisors and senior managers.Ensures adequate staffing and resourcing for all functions within the department.Recommends measures to improve methods, quality of product.Recommends and implements changes in working conditions and use of equipment to increase efficiency of the department.Assists company representatives in quality matters.Supervises and maintains all lab instrumentation – including PM and calibration schedules.Prepares and distributes precise and timely reports as required.Oversees maintenance of all quality control records and samples.Interprets company policies to department workers and enforces safety regulations.Management Representative for manufacturing site Quality Management System (QMS).Communicates all deviations and non-conformances to plant management and senior leadership as needed.Works closely with global quality team.Establishes and oversees internal audit process to ensure site is maintained in an audit ready state.Communicates with authorities and customers, and coordinates the planning and management of audits.Analyzes and approves general and operating procedures, work instructions and other quality-related documents.Develops and maintains site quality metrics and ensures compliance and identification of trends leading to site/process/product improvements.Reviews and approves validation protocols and reports.Ensures that quality-related complaints are investigated and resolved as required.Oversees process for reviews of completed batch production and laboratory control records of critical process steps before release of the products for distribution.Releases or rejects all products. Releases or rejects intermediates for use outside the control of the manufacturing company. Establishes a system to release or reject raw materials, intermediates, packaging, and labeling materials.Ensures a robust stability program supporting product, raw materials, QC Reagents and sets retest/expiry dates and storage conditions where appropriate.Ensures adherence to professional standards and ethics.Provides ad-hoc reports for senior management as required.

MINIMUM REQUIREMENTS

Bachelor of Science in Chemistry or Chemical Engineering.  Advanced degree preferred.Minimum15 years Quality (QA and/or QC) experience required, with at least 8 years at a manager level.Must have hands-on analytical laboratory experience, knowledge of commissioning, qualification, and verification (CQV) process, and experience with performing and hosting audits from regulators and customers.Minimum 5 years’ experience in Quality Systems Management.Has the ability to initiate tasks and work in an independent manner.Must be able to communicate with visitors, vendor, professionals, and plant personnel.  Strong technical capability and must show rapid learning agility.Basic knowledge of quality assurance requirements for pharmaceuticals and medical devices.  Knowledge of ISO 9001 as well as the 19011 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).Proven analytical, evaluative, and root cause analysis 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 application of the Quality Management System (QMS).Product development and project management experience preferred.

Post Code: 001,002

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.