In this role you will be responsible for adhering to and ensuring compliance with cGMP principles and maintain them in effective manner.
Perform in-process quality check activities according to SOP in production / packaging departments (Tablets/Capsules/liquids/Semi solids/Injectable) in complying with cGMP principles and captures test results in batch records.
Check the required tests for all products during production / packaging process.
Inspect and check incoming materials by confirming specifications and return unacceptable materials.
Revise all documents for in process control and perform a quality review of logbooks.
Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system.
Participate in Internal Audit programs.
Preparation of Annual Product Quality Review reports.
Responsible for Deviations and Market Complaint investigations and ensure implementation of CAPA lifecycle.
Ensure the in-process check equipment's are adequately calibrated and functions properly.
Perform and check the line before start (production/packaging) and give the clearance for the work.
Maintain accurate records and perform tests on all activities conducted in the plant.
Maintain safe and healthy work environment by following standards and procedures and complying with regulations.
Perform Self-inspection runs in his areas.
Core Competency :
In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
High on compliance adherence, having strong attention to detail, proactive and flexible
Good communication, interpersonal, and collaboration skills.
Should be having good learners mind to understand and grasp new learnings.