Erika Rocha
Cuautitlán Izcalli, México
Summary
Dynamic professional with experience in quality control and laboratory management in the pharmaceutical industry. Skilled in leading teams and ensuring compliance with GLP and regulatory standards. Combines strategic leadership with technical expertise in problem-solving and analytical techniques. Proven in driving process improvements, managing audits, and delivering results under pressure while seeking new experiences and challenges.
Overview
6
6
years of professional experience
Work History
Co-founder
HERBALUXEE
01.2024 - Current
- Developed and marketed handcrafted cosmetic products, emphasizing practices and innovation
- Managed all operations, including production, branding and customer engagement
Laboratory manager
Qually Corporación S.A. De C.V.
05.2022 - 01.2023
- Directed operations of quality control laboratories for microbiology and physico-chemistry, ensuring compliance with NOM-059, NOM-073, and global standards.
- Spearheaded the installation of new 9 HPLC systems, significantly enhancing analytical capacity and efficiency.
- Conducted investigations of deviations, OOX, and laboratory events, establishing root causes and implementing effective CAPAs.
- Fostered collaboration across departments to decrease urgent delivery times from10 to7 working days.
- Successfully led internal and external audits (weekly) with minor observations, ensuring regulatory compliance.
- Managed and mentored a team of 5 managers and oversaw 25 analysts, promoting continuous improvement and high-quality standards.
Coordinator of Physicochemical Laboratory
Qually Corporación S.A. De C.V
01.2021 - 04.2022
- Managed daily laboratory activities, ensuring strict adherence to GLP.
- Entered data, generated reports, and produced tracking documents.
- Enhanced operational workflows by maintaining well-organized documentation systems and updating records accurately as needed.
- Gathered and organized materials to support operations.
- Provided technical guidance on method implementation, equipment usage, and troubleshooting, enhancing team performance
- Designed and executed controls, reducing analytical errors by30%
- Executed and documented investigations for deviations and out-of-specification results, ensuring alignment with CAPA procedures
- Completed 9 analytical transfer projects within 6 months for clients, including Takeda and Bayer
- Supervised a team of 17 analysts, driving collaboration and technical expertise.
Analytical Chemist
Qually Corporación S.A. De C.V.
07.2019 - 12.2020
- Performed testing on raw materials, in-process products, and finished products using advanced techniques (HPLC, UPLC, dissolution, UV-vis spectroscopy) for clients like Gilead, AstraZeneca, Abbott, and ISDIN.
- Key contributor in analytical transfers and management of highly regulated products, including cytotoxic, hormonal, and controlled substances.
Education
Master's Degree - Chemistry
Chemistry Institute, UNAM
CDMX01.2019
Bachelor’s degree - Chemistry
Chemistry School, UNAM
CDMX06.2016
Skills
- Leadership and management: Laboratory operations, team leadership, cross-functional collaboration, technical mentorship, conflict resolution
- Technical Expertise: Project management, Analytical method transfers, Troubleshooting analytical issues, Method verification, Root Cause analysis, OOS, Internal and external audits, CAPAs, audit finding
- Problem solving: Proficient in problem-solving analytical methodologies from a wide variety of laboratory equipment
- Soft skills: Result-oriented, creative thinking, detail-oriented, strategic decision-making, teamwork, resilience, reliable, assertive communication, autonomy
LANGUAGES
English- Advanced
Spanish- Native
KNOWLEDGE
- Regulatory: NOM-059-SSA1-2015, NOM-073-SSSA1-2015, MXC-17025-IMNC-2018, ICH Guidelines, FEUM, USP, Br. Pharmacopeia, EP.
- Software: Empower, Microsoft, Canva.
Additional Information
Volunteering – Elderly Community
2022 – Present
- Organized activities to promote social well-being among senior citizens.
- Coordinated resources and events to strengthen community engagement.
Active Member – Entrepreneurial Community
2024 – Present
- Engaged in collaborative projects and knowledge-sharing initiatives, driving innovation and best practices.
Timeline
Co-founder
HERBALUXEE
01.2024 - Current
Laboratory manager
Qually Corporación S.A. De C.V.
05.2022 - 01.2023
Coordinator of Physicochemical Laboratory
Qually Corporación S.A. De C.V
01.2021 - 04.2022
Analytical Chemist
Qually Corporación S.A. De C.V.
07.2019 - 12.2020
Master's Degree - Chemistry
Chemistry Institute, UNAM
Bachelor’s degree - Chemistry
Chemistry School, UNAM
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