Quality Control - Pharma Formulation

You will conduct a variety of analytical tests on raw materials, in-process samples, and finished products using laboratory equipment such as HPLC, GC, UV-Vis spectrophotometer, dissolution apparatus, and other instruments. These tests will assess chemical composition, physical properties, and microbiological attributes.

Your role will also include developing and validating analytical test methods for pharmaceutical product analysis in compliance with regulatory guidelines and industry standards. It will be essential to optimize methods for accuracy, precision, sensitivity, and specificity, while ensuring validation requirements are met.

Additionally, you will be responsible for preparing samples for analysis by following proper procedures for sample collection, extraction, dilution, and filtration. Ensuring appropriate handling and storage of samples to prevent contamination, degradation, or loss of integrity will be crucial.

Analyzing test results and interpreting data to evaluate product quality, compliance with specifications, and adherence to regulatory requirements will be another key aspect of your responsibilities. Identifying deviations, out-of-specification (OOS) results, trends, and communicating findings to relevant stakeholders will be important.

Furthermore, you will be expected to perform routine calibration, maintenance, and troubleshooting of laboratory equipment to ensure accuracy, reliability, and compliance with regulatory requirements. Documenting instrument performance and maintenance activities according to established procedures will also be part of your duties.

Maintaining accurate and up-to-date records of analytical testing activities, including test results, laboratory notebooks, instrument logbooks, and electronic data records will be necessary. This documentation should be complete, legible, and traceable for review and audit purposes.

Ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and company policies and procedures will be a critical aspect of your role. Participation in internal and external audits, inspections, and quality assessments, as well as implementing corrective actions when necessary, will be required.

In addition, you will review and approve analytical test data, laboratory reports, and quality control records generated by other analysts or technicians. Verifying the accuracy and completeness of data and documentation before release for further processing or product release will be part of your responsibilities.

Identifying opportunities for process improvement, efficiency gains, and cost savings within the quality control laboratory will be encouraged. Participation in quality improvement initiatives, root cause investigations, and CAPA implementation to enhance overall laboratory performance will be expected.

To qualify for this role, you should have a Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field. Previous experience in a pharmaceutical quality control laboratory, preferably in a cGMP-regulated environment, will be beneficial. Proficiency in analytical techniques and instrumentation, including HPLC, GC, UV-Vis spectrophotometry, and dissolution testing, will be required.

A strong understanding of cGMP regulations, regulatory guidelines (e.g., FDA, ICH), and quality management systems is essential. Excellent attention to detail, organization, and time management skills, along with strong problem-solving and troubleshooting abilities, will be necessary for success in this role.

Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, are also important. Proficiency in MS Office applications and laboratory information management systems (LIMS) will be expected.

Key Skills: quality control, compliance, formulation, testing, documentation, regulatory guidelines, maintenance.,