A Quality Control (QC) Officer is responsible for ensuring that raw materials, in-process materials, finished pharmaceutical products, packaging materials, and laboratory processes meet approved quality specifications and regulatory requirements before products are released for use or sale.
Key Responsibilities
Raw Material Testing:
Collect and analyze samples of active pharmaceutical ingredients (APIs), excipients, and other raw materials.
Perform identification, assay, purity, pH, moisture and other applicable tests.
Verify results against approved specifications.
In-Process and Finished Product Testing:
Analyze products during and after manufacturing.
Carry out tests such as:
Weight variation
Hardness
Friability
Disintegration
Dissolution
Assay
pH
Microbial limits, where applicable.
Ensure results comply with established specifications.
Laboratory Operations:
Operate and maintain laboratory equipment such as HPLC, UV-Visible spectrophotometer, dissolution apparatus, friabilator, disintegration tester, pH meter and analytical balances.
Ensure instruments are properly calibrated and suitable for use.
Perform routine laboratory checks and maintain equipment records.
Documentation:
Accurately record analytical results in laboratory notebooks, worksheets, logbooks and electronic systems.
Prepare Certificates of Analysis (CoAs), where assigned.
Maintain proper documentation in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Deviation and OOS Investigation:
Identify and report Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
Participate in investigations to determine the root cause of abnormal results.
Assist with corrective and preventive actions (CAPA).
Sampling:
Perform or assist with sampling of raw materials, packaging materials, in-process products and finished products according to approved procedures.
Ensure samples are properly labelled, stored and documented.
Compliance and Quality Systems:
Follow approved Standard Operating Procedures (SOPs) and laboratory safety procedures.
Support compliance with GMP, GLP, pharmacopoeial requirements and NAFDAC regulations.
Participate in internal and external audits when required.
Stability Studies:
Assist with stability testing of pharmaceutical products.
Monitor samples stored under specified conditions and document analytical results over time.
Laboratory Safety:
Handle chemicals, reagents and pharmaceutical samples safely.
Ensure proper storage, labelling and disposal of chemicals and laboratory waste.
Follow relevant occupational health and safety requirements.
Typical Qualifications
For a QC Officer position, companies commonly look for:
B.Sc./B.Tech in Chemistry, Biochemistry, Pharmacy, Pharmaceutical Chemistry, Microbiology or a related discipline
Knowledge of GMP and GLP
Knowledge of pharmaceutical analytical techniques
Good documentation and record-keeping skills
Ability to interpret analytical results
Experience with laboratory instruments, particularly HPLC and UV-Vis, is an advantage
Good attention to detail and ability to work according to SOPs
Technical skills:
Analytical chemistry
HPLC analysis
UV-Vis spectroscopy
Titration
Dissolution testing
Assay determination
Pharmaceutical microbiology, depending on the QC section
Data interpretation
Laboratory equipment calibration.
Professional skills:
Attention to detail
Accuracy
Good documentation
Problem-solving
Teamwork
Time management
Integrity and adherence to procedures.
In a company like Sagar Vitaceuticals:
If you're preparing specifically for a QC Officer interview at Sagar Vitaceuticals Nigeria Limited, you should be particularly comfortable discussing tablet/capsule analysis, GMP, HPLC, assay, dissolution, disintegration, friability, hardness, OOS investigations, SOPs, sampling, documentation and NAFDAC requirements.