The role of Executive Trainee – QC is critical for ensuring that products meet regulatory compliance and quality standards through thorough testing, analysis, and documentation. This position is a key entry-level role, ideal for candidates with a background in pharmacy or chemistry, who are ready to grow within a fast-paced quality control environment.
Key Responsibilities
- Testing and Analysis: Perform chemical, functional, and microbiological testing, ensuring results comply with regulatory guidelines.
- Documentation Review & Approval: Ensure all test reports and documents meet the required standards for approval.
- Global Quality Projects: Provide support to global quality initiatives and contribute to gap assessments and productivity projects.
- Raw Material and Product Inspection: Conduct analyses and inspections on raw materials, accessory items, and finished products.
- In-process & Water Testing: Handle in-process and water testing to ensure ongoing compliance.
- Microbiological Testing: Perform sterility tests, BET, microbial enumeration, and cleanroom monitoring.
- Data Recording & Trending: Maintain accurate data records and create trending reports for analysis.
- Calibration & Instrument Qualification: Calibrate glassware and instruments and ensure the qualification of QC equipment and analytical instruments.
- Regulatory Compliance: Ensure all products and processes comply with regulatory requirements like GLP (Good Laboratory Practice) and cGDP (Good Documentation Practice).
- New Product Evaluation: Participate in the evaluation of new products and stability studies.
- Auditing & Training: Help in subcontractor audits and provide necessary training.
- Support Continuous Improvement Initiatives: Assist in WCM (World Class Manufacturing), Lean, Six Sigma, and root cause analysis projects.
Required Qualifications
- Education: Master’s in Chemistry, Bachelor’s or Master’s in Pharmacy (with a focus on Pharmaceutical Analysis, Pharmaceutics, or Pharmaceutical Chemistry).
- Experience: 0 to 2 years in a pharmaceutical industry testing laboratory.
- Technical Skills:
- Instrumental analysis (HPLC, Ion chromatography, UV, GC, FTIR).
- Microbiological testing (environmental monitoring, sterility, microbial identification, bacterial endotoxin testing).
- Familiarity with tests according to Pharmacopoeial requirements (USP/IP/EP).
- Understanding of chemical and microbiological analysis.
- Knowledge of USFDA and EuGMP requirements (preferred).
Additional Skills & Competencies
- Attention to Detail: Strong data integrity and documentation skills.
- Communication: Ability to clearly communicate technical findings and participate in discussions.
- Problem Solving: Ability to manage multiple tasks and priorities, working efficiently to resolve issues.
- Shift Flexibility: Willingness to work across all shifts, including night shifts when required.
- Travel Requirements: Ability to travel across India based on business needs.
Terumo BCT Core Competencies
- Integrity: Responsibility for life and health, maintaining a mission-driven approach.
- Quality Focus: Commitment to safety and quality at every stage of the manufacturing process.
- Creativity: A passion for innovation and tackling challenges with a future-focused mindset.
