Quality Project Engineer

hace 1 día

Silao, Guanajuato, México Beiersdorf A tiempo completo

Your Tasks

Ensure the proper planning, documentation, evaluation, and execution of change control, design review, commissioning, qualification, and validation processes for equipment, facilities, computerized systems, and critical systems within projects at a regulated manufacturing plant (OTC and cosmetics), ensuring compliance with applicable national and international regulations and the Quality Management System.

Key Responsibilities

  • Evaluate and approve URS, FAT/SAT protocols, commissioning, and qualification/validation activities for equipment, facilities, and critical systems.
  • Prepare, review, and ensure compliance of qualification and validation protocols in accordance with GMP and international standards (ISO, GAMP 5, CFR 21 Part 11, WHO, among others).
  • Manage and maintain project documentation related to the Quality Management System.
  • Manage and follow up on change controls, ensuring GMP compliance.
  • Participate in internal and external quality audits, providing technical support and responses.
  • Coordinate and participate in quality risk assessments for assigned projects.
  • Update and/or develop procedures aligned with applicable regulations and plant requirements.
  • Ensure compliance with environmental, health, and safety policies.
  • If applicable, manage direct reports by conducting performance evaluations, providing feedback, setting objectives, monitoring KPIs, and following up on annual training plans.

Your Profile

  • Minimum of 4 years of experience in validation and quality projects within the cosmetic and/or pharmaceutical industry.
  • Experience with manufacturing and filling equipment for liquid and semi-solid products.
  • Knowledge of the lifecycle of equipment, facilities, and critical systems.
  • Experience with Quality Management Systems (GxP, CAPA, deviations, change control).
  • Education: Bachelor's degree in Pharmaceutical Chemistry (QFB/QFI), Chemical Engineering, Biochemistry, Biotechnology, or related field.
  • English : Advance

Technical Knowledge

  • Good Documentation Practices (GDP).
  • Regulations: COFEPRIS, FDA, Health Canada.
  • Guidelines and standards: GAMP 5, ISO 14644, ISO 8573, ICH, ISPE, WHO.
  • Quality risk assessment and project management.

Competencies

  • Integrity
  • Decision-making
  • Strategic vision
  • Leadership

At Beiersdorf, we want to help people feel good about their skin – and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment and society.

Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live an inclusive culture of respect and trust that is strongly aligned with our values – CARE, COURAGE, SIMPLICITY and TRUST. We also embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.

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