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Quality Control Analyst 1886444973 About the Company: IGC Pharma SAS, based in Bogota, is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company that focuses on preventing and managing Alzheimer's and other CNS diseases.
We are an exciting, young company... Job Description: The Quality Control Analyst will coordinate and oversee all quality control activities at IGC Pharma, working closely with our third-party laboratory to ensure that all raw materials, in-process samples, and finished pharmaceutical products meet the required internal specifications.
The role involves reviewing analytical data, managing product release processes, and ensuring compliance with cGMP 211, regulatory requirements, and company quality standards.
This position will report to the Quality Assurance (QA) lead and collaborate cross-functionally with manufacturing and regulatory teams.
Key Responsibilities: Coordinate third-party laboratory interactions, ensuring timely and accurate testing of raw materials, intermediates, and finished products.
Review and translate from English to Spanish Method Validations /Verifications/Scopes/Challenges.
Review and approve laboratory test results, certificates of analysis (CoAs), and investigations related to out-of-specification (OOS) results or deviations.
Ensure compliance with GMP, regulatory guidelines (e.g., FDA, EMA), and internal quality policies by monitoring QC activities.
Coordinate product release processes by verifying all quality documentation and ensuring specifications are met before distribution.
Assist in stability studies by coordinating testing schedules and reviewing reports from the third-party laboratory.
Develop and maintain Standard Operating Procedures (SOPs) related to quality control activities.
Participate in audits and inspections, providing necessary documentation and ensuring QC-related compliance.
Support quality investigations and CAPAs (Corrective and Preventive Actions) related to analytical testing issues.
Assist in the creation of Specifications and Quality Course Trainings for the Company.
Work closely with the QA team to implement continuous improvement initiatives in quality control processes.
Qualifications: Bachelor's degree in pharmacy, chemistry, microbiology, or a related field.
2-10 years of experience in pharmaceutical quality control, preferably in a company using third-party laboratories.
Proficiency in English (writing and reading) to carry out the documentation functions.
Strong understanding of GMP, ICH guidelines, and regulatory requirements for pharmaceutical testing.
Experience with reviewing analytical data, CoAs, and QC documentation.
Knowledge of laboratory testing techniques for pharmaceutical products, including HPLC, GC, and microbiological assays.
Excellent organizational skills, attention to detail and ability to manage multiple tasks in a fast-paced environment.
Strong communication skills to liaise effectively with third-party labs and internal teams.
Experience in handling deviations, OOS investigations, and CAPA processes is a plus.
* Salary is negotiable depending on experience and academic background.
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