What are the responsibilities and job description for the Quality Control Manager position at Dr. Simi?
Company Description
Dr. Simi is the US subsidiary of Farmacias de Similares, the largest pharmacy chain in Latin America. The company offers a wide range of health and wellness products through its online platform. Dr. Simi is set to expand its presence with the upcoming opening of its flagship Similandia store in Los Angeles, California. The organization focuses on providing accessible healthcare solutions to communities.
Job Overview:
The QC Manager will ensure that the facilities operations in the Distribution Center comply with the requirements established by FDA and NOM-059-SSA1, Supplement to the Pharmacopoeia for establishments dedicated to the sale and distribution of health supplies, in order to comply with the health authority and guarantee that the quality and integrity of the health supplies that are stored and distributed in the CEDIS are maintained, to achieve the satisfaction of our customers.
PRINCIPAL FUNCTIONS:
1. To assess the products received at the distribution centers and CEDIS, based on the results of physical inspection and review of the analytical certificate (when applicable), to ensure that the products distributed meet the quality specifications.
2. Assign to the Quality Control Inspector, the products to be inspected, based on the workload, for their input in the systems (approval or rejection) and availability in the warehouse and CEDIS for the assortment.
3. Review and approve the inspection reports made by the Quality Control Inspector, comparing the information of the reports against captured in the system, in order to ensure that the information is true and correct.
4. Supervise that the QC inspectors comply with the assigned activities and internal policies of the company.
5. Make requests for action to correct quality defects found during the product inspection, to notify the supplier and follow up until they are corrected.
6. Ensure that customer complaints are addressed, through follow-up's on the corporate portal, to promote continuous improvement.
7. Follow up on returns from pharmacies due to quality defects, based on the current procedure, and indicate the final disposal of the product (return to the supplier or destruction).
8. Prepare and analyze the monthly report of the products inspected per month, based on the information obtained from the inspection reports and the system, to evaluate the quality compliance of the suppliers.
9. Safeguard the certificates of analysis sent by suppliers through the electronic file, to ensure that the batches received meet quality specifications.
10. Ensure that the quality management system is applied and maintained, through the continuous review of indicators, to ensure compliance and continuous improvement.
11. Authorize in writing the documents (PNO's, Quality Management Manual, etc.) related to the quality management system in accordance with the applicable regulations, to comply with the requirements of health legislation.
12. Attend in person the verification visits carried out by the health authority or designate, in writing, who will represent them in them, in case of absence.
13. Verify that internal audits are carried out, reviewing compliance with the pre-established program, so that the necessary corrective measures are adopted and the improvement of the system is achieved.
14. Review and authorize internal audit and management review reports to ensure that the warehouse, distribution centers and CEDIS comply with Good Storage Practices and sanitary requirements (NOM-059-SSA1 and Pharmacopoeia Supplement).
15. Verify that initial and continuous training is carried out for personnel, regarding the topics of FDA, GAP, PNO's, safety and hygiene.
16. Ensure that the product recall is carried out as described in the current procedure, to achieve compliance with the regulations from the FDA and (NOM-059-SSA1)
EXPERIENCE:
• Proven experience in quality control or a related field is preferred, with a strong understanding of QA/QC processes.
• Familiarity with quality inspection techniques, data collection methods, and quality management systems is essential.
• Experience in conducting quality audits and implementing corrective actions based on findings is highly desirable.
• Strong analytical skills with the ability to interpret complex data sets effectively.
• Excellent attention to detail, organizational skills, and the ability to work independently or as part of a team.
• 2 to 3 years of experience as a Health Manager in warehouses for the deposit and distribution of medicines and other health supplies.
• Knowledge of application of NOM-059-SSA 1 and FDA regulations and other regulations applicable to warehouses for the deposit and distribution of medicines for health supplies
• Knowledge of Quality Management Systems and continuous improvement.
• Knowledge of quality processes for the manufacture of medicines and other health supplies
TECHNICAL SKILLS:
· Knowledge of NOM-059-SSA1, FDA, FEUM Supplement and others applied to the business.
· Knowledge in Quality Management System.
· Application of Continuous Improvement, and the regulations of Good Practices Good Storage and Distribution.
· Knowledge in Document Control and PNO's