A Quality Control (QC) Officer in the pharmaceutical industry ensures that products meet quality standards and regulatory requirements throughout the manufacturing process. Their responsibilities include analysing raw materials, in-process samples, and finished products, maintaining instruments, and ensuring adherence to cGMP and other relevant guidelines. They also document findings, investigate deviations, and support continuous improvement efforts.
Key Responsibilities:
Sampling and Analysis:
Collecting and testing samples of raw materials, in-process materials, and finished products.
Performing various analytical techniques, including wet chemistry and instrumental analysis.
Analysing stability samples and preparing stability trend reports.
Status labelling of quality control Instruments, Chemical & Glassware.
Disposal of balance samples after completion of analysis and its documentation.
Instrument Maintenance and Calibration:
Maintaining and calibrating QC instruments, including HPLC, spectrophotometers, etc.
Documentation and Record Keeping:
Maintaining detailed records of analysis, including instrument logbooks, method validations, and SOPs.
Preparing and reviewing stability protocols and reports.
Preparation of certificates of analysis (COA)
Method Validation and Transfer:
Participating in method validation and transfer activities.
Deviation Reporting and CAPA:
Reporting and investigating deviations from established procedures and specifications.
Participating in the development and implementation of corrective and preventative actions (CAPAs).
Compliance and Auditing:
Ensuring compliance with cGMP, ICH, USFDA, ISO, and other relevant guidelines.
Providing documentation to auditors and assisting with audit activities.
Continuous Improvement:
Identifying areas for improvement in QC processes and procedures.
Supporting the implementation of new technologies and methods.
Qualifications:
Bachelor's degree in chemistry, pharmacy, M.Sc. (Chemistry) or a related field.
Experience in pharmaceutical QC, preferably with a focus on analytical chemistry.
Knowledge of cGMP, ICH, USFDA, and other relevant guidelines.
Proficiency in various analytical techniques and instrumentation.
Strong analytical, problem-solving, and communication skills.
Job Types: Full-time, Permanent
Pay: ₹11,284.71 - ₹20,000.00 per month
Benefits:
Paid sick time
Provident Fund
Schedule:
Rotational shift
Supplemental Pay:
Overtime pay
Yearly bonus
Work Location: In person