Job Purpose To perform manual visual inspection of sterile injectable products in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and regulatory requirements, ensuring only defect-free products are released for further processing.
Key Responsibilities
- Perform manual visual inspection of vials, ampoules and other injectable products under qualified inspection conditions.
- Identify and segregate defective units based on critical, major, and minor defects .
- Ensure inspection is carried out as per approved SOPs and batch manufacturing records.
- Maintain prescribed inspection speed without compromising product quality.
- Record inspection output, rejection details, and other production records accurately.
- Ensure compliance with Good Documentation Practices (GDP).
- Follow gowning procedures and maintain aseptic discipline in controlled areas.
- Report any abnormality, equipment malfunction, or quality concern to the supervisor immediately.
- Participate in visual inspection qualification and periodic requalification programs.
- Adhere to EHS, Data Integrity, and company policies at all times.
- Support investigations related to visual inspection defects, deviations, and customer complaints, whenever required.
Qualifications
- ITI / Diploma / B.Sc. (Preferred)
- Experience in sterile injectable manufacturing will be an added advantage.
Experience
- 1 to 6 years of experience in Manual Visual Inspection of sterile injectable products.
Required Skills
- Knowledge of cGMP and Good Documentation Practices.
- Ability to identify visible defects accurately.
- Valuable eyesight and colour vision (without colour blindness).
- High level of concentration and attention to detail.