Sr. Management - Quality Assurance - Api Job in Rusan Pharma

Opening for Sr. Management - Corporate Quality Assurance - API (Ankleshwar)

with Rusan Pharma Ltd

Qualification : M.sc

Exp : 12+ Years - API Background

Location : Ankleshwar (API)

Responsible for managing QA activities such as deviation management, change management, SOP compliance, batch release, supplier quality assurance, complaint handling and document review.

Preparation, Review and Maintaining corporate QMS SOPs. (Deviation, Change control, Audit Management, Complaints, Self Inspection, and document reviews).

Market complaints - Investigation, CAPA analysis, resolution of complaints & taking timely corrective action for critical and major categories.

Managing QA activities such as deviation management, change management, SOP compliance, batch release, supplier quality assurance, complaint handling and document review

preparation / review of various protocols and reports such as cleaning validation, process validation, validation master plan, computerized system validation, etc

Communication with international corporate colleagues on various subjects.

Preparing monthly and yearly reports with respect to QA activities and presenting the same to corporate QA.

Preparation of the site qualification and validation master plan for current year and tracking the progress plan on quarterly basis.

Preparation and Implementation of internal audit program.

Documentation, Validation & Qualification, Internal & External Audit, handling Customer Complaints and indepth knowledge of Regulatory requirements