Assist QA Inspection Manager in all in-process and inspection checks of production operations and facilities (e.g., building / environmental / equipment / utilities / systems etc.) per Abbott Policies, AQ, EQDs, SOPs, GMP and Drug Act 1976. Perform GEMBA of respective areas to assure inspection readiness and verify that area logbooks and other documents are maintained with reference to Data integrity. Additionally, perform sampling of bulk, intermediate and finished products as per respective sampling plans.

Major Responsibilities:

• To make sure that activity does not result in,

• Delay or non-availability of product.
• Delay in introduction of new products.

• Any non-compliance of cGMP (current Good Manufacturing Practices), GSP (Good Storage Practices) and EHS (Environment, Health & Safety) requirement.           
• Line clearance and In process checks of production manufacturing and finishing operations, GEMBA Inspection of Warehouses, Utilities and facilities (e.g., building / environmental / equipment / utilities / systems etc.) per Abbott Policies / Procedures, and cGMP Guidelines.
• To assure verification of all necessary checks and requirements for the dispensing activities before granting line clearances as per respective procedures.
• Raw Materials issue verifications as per approved Manufacturing Shop Order.
• Packaging Commodities Issue verifications as per approved Finishing Shop Order.
• Perform sampling activities as and when required per the applicable procedures.
• Maintain and improve existing quality processes to assure continuously appropriate and compliant operations in production and storage areas.
• Responsible for SOP write up / Revision / Implementation as per AQ, EQDs, SOPs, Drug Act, cGMP etc.
• To ensure that all necessary documentation is completed accurately in respective areas, in a timely manner, and in compliance with data integrity and regulatory requirements.
• To ensure calibration / verification of equipment / instruments used for In-process checks.
• To participate in Validation and Qualification activities related to Process, Equipment and Facilities, whenever required.
• Audit follow-up for corrective action implementation in his/her area of activity.
• To actively participate in handling of exception reports, internal quality investigations and customer complaints related to his / her area for root cause identification and CAPA implementation.
• To ensure that workplace is compliant with all applicable health and safety regulations. Report any workplace safety / near miss incidents and follow-up till closure.
• Handling of Regulatory samples for submitting to respective Drug Inspectors.
• To assist QA Inspection Manager in data collection for PQR.
• Any special project assigned by QA Inspection Manager.
• Work closely with other departments to facilitate in maintaining compliance of the applicable systems for change controls, CAPA, ERs, complaints, internal GxP audit observation follow ups and CAPA effectiveness.
• Proceed for Rejected material incineration activity when assigned.

Education/Knowledge & Experience:

• Science Graduate/Master; preferably Chemist/Pharm D
• 2-3 years’ experience in the same capacity 
• Knowledge of QA documentation, technical problem resolution, and other all activities taking place in QA
• Proficient in MS Office
• Analytical Skills