The incumbent will be responsible for executing all in-process sampling and inspection, ensuring that all associated documentation and GMP practices applicable to Fill and Pack as well as product storage are satisfactorily complied with to generate products that meet specification and regulatory requirements.
He ensures overall GMP compliance of the Fill & Pack Operation and takes decision on product release status after a careful consideration of all applicable standards.
Responsibilities
Follow safety and quality-related instructions and communicate deviations to superior.
Perform regular in process control (IPC) activities in compliance with standard operating procedure
Ensure line clearance activities are correctly and appropriately executed before line opening
Collect test and retention samples according to sampling plan
Ensure through regular checks that all quality criteria are met during the shift operation.
Responsible for precise documentation of quality checks to enable traceability.
Release production at the beginning of the shift and new production order.
Ensure day to day quality control compliance with GMP & quality system procedures
Work with the operations team to support the investigation of deviations and resolution of quality issues.
Ensure implementation of corrective and preventive actions (CAPA) and its effectiveness check.
Ensure and monitor the validation activities of filling line machines.
Access the impact of changes & ensure the closure of the change control as per the procedure.
Ensure swab collection after cleaning & sanitization activity of any line.
Perform applicable laboratory tests if and whenever required.
Carry out overall finished goods inspection online, before & after packing into shipper.
Takes final disposition on the quality of finished products.
Monitor rework and VAS activities whenever required to ensure effectiveness of execution and compliance to GMP.
Carry out induction and regular training for shop floor and warehouse teams and measure training effectiveness as it relates to GMP, GWP, Hygiene and QMS requirements.
Monitor the operations team to ensure all in-process checks expected to be carried out by them are properly executed.
Generate proposals for further improvements and follow up to achieve satisfactory implementation (Continuous improvement process)
Ensure satisfactory results from regulatory inspections at fill and pack
Participate in key QMS processes on site including internal audit, risk assessments, RCA sessions etc.
Co-ordinate, Monitor and generate FFPR report for NPDs and EPDs.
Requirements
Minimum of B.Sc in Science or B.Eng in Engineering related course.
Minimum of 3 years’ experience in production of consumer goods (e.g. drugs, food, cosmetics)
Excellent Process understanding
Appreciation of other work disciplines, such as operations
Microsoft Office (Excel, PowerPoint, Word), SAP (PP1, PE2).
Good communication, leadership and training skills.