Assistant Manager - Quality Assurance ( Pharmaceuticals)

Role & responsibilities

• Timely renewal of license and certification
• Review and approve process validation protocol and its reports
• Review and approve cleaning validation protocol and its reports
• To Ensure that procedure and specification are appropriate and followed
• To Ensure that in process controls are implemented, performed during operation and results are satisfactory.
• To ensure preparation and issuance of documents.
• Ensure that outside party calibration and validations are done as per schedule
• Responsible for document management system
• Resolve customer queries
• Responsible for internal and external audits.
• To ensure proper trainings are carried out.
• Responsible for Batch release in absence of Quality Assurance Manager
• Prepare all regulatory protocols
• Manage the CAPA system and ensure that appropriate corrective and preventive actions are implemented.
• Handling of market complaints of Products
• Annual product review for the Products
• Implementing recall procedures if necessary
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Review and approval of Site Master file and Master validation Plan
• May perform additional duties as required.

Preferred candidate profile

• Candidate should be Pharmaceutical Background.
• Excellent Communication
• Should be process and result oriented
• Should take responsibility and achieve the objective