Preferred Industry Experience
Candidates must have hands-on experience in at least one of the following regulated manufacturing sectors:
- Sterile / Injectable Manufacturing
- Medical Device Manufacturing
- Medicinal Equipment Manufacturing
Position Overview
We are seeking a proactive, detail-oriented, and quality-focused QC Engineer with 3–5 years of experience in sterile, cleanroom, or other regulated manufacturing environments. The ideal candidate will be responsible for ensuring product quality through analytical testing, compliance with pharmacopeial standards, and adherence to Good Manufacturing Practices (GMP).
Key Responsibilities
- Perform testing of raw materials, in-process samples, finished products, and packaging materials in accordance with pharmacopeial standards (IP, BP, USP, Ph. Eur.).
- Conduct analytical testing, including assays, dissolution, impurity profiling, identification tests, and related quality control analyses.
- Carry out wet chemistry testing such as pH, conductivity, titration, and other routine laboratory analyses.
- Operate, calibrate, and maintain analytical instruments including IR Spectroscopy, FTIR, pH meters, conductivity meters, and other laboratory equipment.
- Ensure compliance with GMP, GLP, SOPs, and data integrity requirements.
- Prepare and maintain accurate laboratory documentation, including test records, calibration logs, analytical reports, deviations, change controls, and laboratory notebooks.
- Coordinate with Quality Assurance (QA), Production, and Engineering teams to investigate quality issues and implement corrective actions.
- Support internal, customer, and regulatory audits by maintaining audit-ready documentation and participating in audit activities.
- Perform sample collection, labeling, storage, retention, and support stability studies in accordance with established procedures.
- Participate in method validation, method transfer, instrument qualification, and continuous process improvement initiatives.
- Ensure compliance with cleanroom practices and laboratory safety standards.
Candidate Requirements
Education (Preferred)
- B.Sc. / M.Sc. in Chemistry
- B.Pharm. / M.Pharm. (Pharmaceutical Chemistry or related specialization)
Experience
- 3–5 years of Quality Control experience in a pharmaceutical, sterile manufacturing, medical device, or other regulated manufacturing environment.
- Prior experience in sterile, injectable, medical device, or cleanroom operations is mandatory.
Technical Skills
- Strong knowledge of pharmacopeial testing (IP, BP, USP, Ph. Eur.).
- Hands-on experience with analytical instruments such as IR Spectroscopy, FTIR, pH meters, and conductivity meters.
- Familiarity with method validation, method transfer, and instrument calibration.
- Sound understanding of GMP, GLP, data integrity (ALCOA+ principles), and cleanroom compliance.
- Proficiency in laboratory documentation and quality management systems.
Key Competencies
- Strong analytical and problem-solving skills.
- High attention to detail and accuracy.
- Effective communication and cross-functional collaboration.
- Ability to work independently and manage multiple priorities.
- Commitment to quality, regulatory compliance, and continuous improvement.
