Tata Consulting Engineers
In plant assignment located in Pt. Neches, TX.
Summary:
The Quality Assurance (QA) Lead Coordinator ensures the establishment, implementation, and maintenance of the Quality Management System (QMS) through audits, aiming for compliance and continuous improvement of the Quality and Food Safety System. This role promotes preventive actions to meet regulatory standards (HACCP, GMPs, ISO 9001, EFFCI, among others) and monitors non-conformances arising from various sources, ensuring products and processes are in line with the client.
Overview:
Our quality engineering, sustainable solutions and safety record inspire everything we do. Our diverse and inclusive workforce allows for all employees to feel valued and safe to give their opinions and improve our company.
Tata Consulting Engineers USA, LLC, (TCE), is a multi-disciplinary engineering organization offering a full range of integrated engineering design, project support, procurement and construction management services to the energy and chemicals industries.
Qualifications include but are not limited to:
Experience Establishing, implementation and maintenance of the Quality Management System (QMS).
Auditing Experience.
Experience Ensuring that the quality and safety requirements of the products and production processes are met, adhering to standards and policies (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC2200, EFfCI, Kosher, Halal, etc.).
Previous in plant experience required.
Responsibilities include but are not limited to:
Support Quality and Safety Management System Manager, Product Safety and Committee Leader.
Leader of the Product Safety Committees of all units for validation issues.
Complete Internal Auditor.
Manage the execution of the Validation Master Plan.
Manage the updating and generating of procedures and protocols for the validation of equipment, systems and/or processes.
Quality Management and Compliance.
Define KPI's and criteria with continuous improvement and approach.
Update and assist in managing Document Management Systems.
Promote and ensure compliance.
Ensure that the quality and safety requirements of the products and production processes are met, adhering to standards and policies (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC2200, EFfCI, Kosher, Halal, etc.).
Implement GMP practices applicable to Quality Assurance.
Develop initiatives and programs to promote quality standards.
Develop and deliver training.
Manage budget and process invoices.
Support other functions in QA-related aspects or inquiries.
Coordinate recall, non-conformance and food safety teams.
Maintain the QMS/ FSMS to keep all quality and food certifications: FSSC 22000, ISO 9001:2015, EFfCI, Kosher, Halal, and RSPO.
Develop and monitor the annual internal and external audit program, including implementation.
Pharma/ EXCiPACT expert – lead pharma certification projects.
Risk, Validation & Compliance
Develop cleaning and CCP (Critical Control Points) validations.
Continuously ensure compliance with validation programs and plans, as well as the evaluation of revalidation needs.
Execute validations in accordance with the validation master plan and applicable protocols.
Investigate system NCRs and root cause failure analysis.
Audit Responsibilities
Develop and manage audit schedules.
Coordinate internal and external audit scopes, objectives, and timelines.
Assign internal and external auditors, ensuring appropriate expertise and availability.
Maintain a qualified audit team and engage external consultants as needed.
Oversee audit execution and compliance.
Review and approve audit reports.
Document and follow up through to closure on audit findings.
Collaborate on action plans for audit findings, and
Monitor trends and share insights from audit findings with leadership.
Conduct internal audits and manage audit processes.
Tracking and Follow-Up
Manage the follow-up of non-conformities and contribute to the preparation of root cause analyses.
Ensure all audit findings are documented and followed through to closure.
Monitor the quality metrics and report status to senior management.
Develop and monitor the annual internal and external audit program, including implementation.
Regulatory Developments
Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, seeking continuous improvement.
Implement new quality certifications aligned with business strategy.
Monitor the Foreign Supplier Verification Program-FDA.
Assess legal requirements applicable to various sites.
Qualify and monitor suppliers, supporting supplier audits.
Carry out and follow up on the supplier audits and internal audits program.
Selection and monitoring of suppliers.
Manage customer paperwork required for quality critical analysis (questionnaires, quality agreements, contracts, statements).
Define KPIs and their criteria with a continuous improvement approach and governance.
Promote, influence, and ensure compliance with the Quality and Safety Management System.
Develop initiatives and programs to promote quality standards.
Implement and train risk analysis: FMEA & HACCP.
Promote continuous improvement for quality processes based on external benchmarking.
EEO Statement
Tata Consulting Engineers USA, LLC (“TCE”) is an equal opportunity and affirmative action employer committed to promoting diversity, equity, and inclusion in our workplace. We do not discriminate on the basis of race/ethnicity, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, veteran's status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
In compliance with federal law, all candidates hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form after acceptance of a formal TCE offer letter through our onboarding system.
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