Quality Assurance Supervisor

Description

Position Summary: A Quality Assurance professional with experience in the pharmaceutical/chemical industry, focused on regulatory compliance, process supervision, and document management. Key Highlights: 1. Over 5 years of experience in pharmaceutical/chemical Quality Assurance 2. Proficiency in national and international regulations 3. Supervision and compliance with GMP/BPM and GDP Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Chemistry and Biology, Pharmaceutical Chemistry, Biomedical Engineering, Pharmaceutical Engineering, or related field. Minimum 5 years of Quality Assurance experience (pharmaceutical or chemical industry). Proficiency in national and international regulations applicable to the chemical and pharmaceutical industries. Intermediate-to-advanced Excel. Experience with ERP and DMS (desirable).\[CE1] Experience in regulatory audits. Intermediate-to-advanced English: B2 \[CE1]It may be advisable to list here the software systems we will use. It is highly likely that candidates will already know how to use an ERP and a DMS, as these are rarely absent from manufacturing plants. Supervise the implementation of Good Manufacturing Practices (GMP/BPM) and Good Documentation Practices (GDP) across production processes.\[CE1] \[CE2] Conduct on-site verification that manufacturing processes are carried out in accordance with established procedures. Review, compile, and safeguard product Batch Record documentation. Provide training on GMP and Quality Management System (QMS) processes. Maintain up-to-date QMS documents. Verify the validity and compliance of quality system procedures. Manage documentation: audits, complaints, change controls, deviations, risk assessments, and annual product reviews. Follow up on internal and external audits (customers, COFEPRIS, FDA, INVIMA, among others). Coordinate document control and issuance of procedures to production.\[CE3] \[CE1]This is very important — it reflects a comment Bernardo made during my presentation last Tuesday, since currently we do not perform floor verification; only document review is conducted. \[CE2]The point I added addresses this need; however, you could discuss with Fer whether he agrees with orienting the profile toward this direction. \[CE3]It seems this point is already covered by several of the earlier points regarding the QMS, but if we wish to emphasize the relationship with and service to the manufacturing plant, it could instead state: Coordinate, review, and control the issuance of documents used for product manufacturing. Salary: $22,000\.00 \- $23,000\.00 per month Benefits: * Medical expense insurance * Dental insurance * Cafeteria service * Additional vacation days or paid leave Work location: On-site employment