Lee Pharma - Quality Control Role (15-20 yrs)

Job Description:

- Implementation of Laboratory requirement and enhancements to increase efficiency and ensure compliance.

- Responsible for compliance with respect to Quality compliance requirements for Laboratory application softwares and Data Integrity requirements.

- Lead Regulatory audits and its readiness.

- Supporting of verification of audit trail generated by the respective application softwares of Laboratory instruments.

- Supporting to Date and time verification of laboratory instruments.

- Handling of Quality Management system like Laboratory Incident, Out of Specification, Deviation, CAPA, and Change control.

- Involving in the laboratory investigation and find out root cause for error and implemented CAPA to eliminate those error.

- Coordination with QA/CQA & RA for QMS activity.

- Ensuring that all the investigation completed within the timeline.

- Maintaining QMS tracker for the status of each QMS document.

- Ensuring effective functioning of the department activities.

- Manpower planning for regular shift activities.

- Assigning job responsibilities to overall Routine team.

- Providing technical expertise and leadership to meet specified timelines.

- Ensuring Quality of In-process, intermediates and finished products.

- Monitoring the Analytical method transfer activities whenever required and overall Supervision of quality control laboratory.

- Maintaining 5S activity in laboratory

- Maintaining system as per GLP, GDP and cGMP

- Monitoring the all kinds of Investigation (Finished products and Raw materials), deviations, OOS, OOT, Customer complaints and incidents etc

- Monitoring of effective implementation of ISO 9001 &14001 standards

- Conducting of all trainings related to GLP, cGMP & on the job trainings for all personals.

- Maintenance of Annual Maintenance Contract (AMC).

- Reduce the consumption maximum, Recycle as possible as, Reuse optimum level for all natural resources