* Develops and implements visual inspection procedures, including SOPs and work
instructions, for manual, semi-automatic, or fully automatic systems inline
with SOP/ Regulatory requirements.
* Ensure Visual inspection is being performed as per respective SOP.
* To ensure availability of sufficient VI inspector as per process
requirements.
* Good hands-on KNAPP kit preparation & qualification activity.
* Ensures all products adhere to quality, safety, and regulatory standards
(e.g., FDA, EMA, ICH).
* Hires, trains, and manages inspectors, ensuring high-performing, compliant,
and motivated staff.
* Monitors inspection processes, analyses data for trends, and initiates
corrective actions (CAPA) or process improvements.
* Collaborates with Engineering to validate equipment and maintain inspection
limits.
* Collaborates with SCM, MFg. to plan VI activity to meet business
requirements.
* Prepare & Reviews batch records, deviation reports, and face
internal/regulatory audits.
* Compliance of audit observations.
Skills Required:
* Positive Manufacturing Practice (GMP)- Expert
* Regulatory Compliance- Expert
* SOP and Document Review & Approval - Expert
* Handling of packing and visual operations- Expert