Jefe de Control de Calidad Analítica

Placements24; Monterrey; On-site; MXN 700,000 - 1,000,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Retirement savings plans

On-site position in Monterrey

Training and development opportunities

Job summary

Placements24 seeks a Jefe de Control de Calidad Analítica to lead the analytical laboratory in Monterrey, ensuring rigorous testing for raw materials, in-process samples, and finished products. The role demands expertise in HPLC, GC, MS, spectroscopy, method development, and validation, with a strong GMP focus.

The successful candidate will supervise and train analysts, oversee CAPA processes, and ensure data integrity for regulatory compliance and product release in a fast-paced pharmaceutical

Qualifications

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related analytical science field.
• 6+ years in pharmaceutical analytical testing and quality control with at least 2 years in leadership.
• Expertise in HPLC, GC, UV-Vis, IR spectroscopy, and Mass Spectrometry.

Responsibilities

• Lead and manage the analytical quality control laboratory, ensuring efficient and compliant operations.
• Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products.
• Oversee routine testing, stability studies, and release testing of pharmaceutical products.
• Ensure GMP, ICH guidelines, and other regulatory requirements.
• Manage laboratory equipment, including calibration, maintenance, and qualification.
• Supervise and mentor laboratory analysts to foster a high-performance team.

Skills

Laboratory leadership

Analytical testing

Regulatory compliance

Quality management

CAPA

Education

Bachelor's or Master's in Chemistry

Tools

HPLC

GC

Mass Spectrometry

Spectroscopy

Job description

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking an experienced and meticulous Jefe de Control de Calidad Analítica to lead their analytical laboratory operations in Monterrey, Nuevo León, MX . This role is essential for ensuring the quality and integrity of raw materials, in-process samples, and finished pharmaceutical products through rigorous analytical testing. The ideal candidate will possess extensive knowledge of analytical techniques (HPLC, GC, MS, spectroscopy), method development, validation, and a strong understanding of pharmaceutical quality regulations. You will manage a team of skilled analysts, oversee laboratory operations, and ensure compliance with GMP and other relevant standards. Your leadership will guarantee the accuracy and reliability of analytical data, supporting product release and regulatory compliance. We are looking for a scientifically adept and quality-driven professional.

Key Responsibilities

• Lead and manage the analytical quality control laboratory, ensuring efficient and compliant operations.
• Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products.
• Oversee routine testing, stability studies, and release testing of pharmaceutical products.
• Ensure compliance with GMP, ICH guidelines, and other relevant regulatory requirements.
• Manage laboratory equipment, including calibration, maintenance, and qualification.
• Supervise, train, and mentor laboratory analysts, fostering a high-performance team culture.
• Investigate out-of-specification (OOS) results and deviations, implementing corrective and preventive actions (CAPA).
• Prepare and review analytical test reports, method validation documents, and other quality records.
• Liaise with R&D, production, and regulatory affairs departments to support product development and manufacturing.

Requirements

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related analytical science field.
• Minimum of 6 years of experience in pharmaceutical analytical testing and quality control, with at least 2 years in a supervisory or leadership role.
• Expertise in various analytical techniques such as HPLC, GC, UV-Vis, IR spectroscopy, and Mass Spectrometry.
• Strong knowledge of method development and validation principles.
• Proficiency in GMP regulations and quality management systems within the pharmaceutical industry.
• Excellent leadership, organizational, and problem-solving skills.
• Strong attention to detail and ability to work accurately under pressure.
• Effective communication and interpersonal skills.
• Must be able to work on-site in Monterrey, Nuevo León, MX .

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, as well as retirement savings plans.
• This on-site position provides the opportunity to work with advanced analytical instrumentation in a key pharmaceutical hub.
• We are committed to fostering employee growth through continuous training and development opportunities.
• You will play a crucial role in ensuring the quality and safety of pharmaceutical products.
• Paid time off and performance-based incentives are part of the package.
• Join a collaborative team dedicated to scientific excellence in Monterrey, Nuevo León, MX .