Assistant Manager I, Quality Compliance

Job Description:

Responsibilities

• Implementation of Zentiva Global Quality & Regulatory policies & guidelines, review and approval of GxP Documents e.g. Quality Manual, SOPs, Process Validation reports, Master Batch Records, Finished Product specifications, Master Documents, etc.
• Submission to regulatory authorities associated with various regulatory requirements, authoring / or coordinating RA activities for new registrations / licenses, post approval changes, renewals, GMP Certification applications, annual reports and line extensions to meet requirements.
• Coordinating and contributing to responses to Agency queries and performing quality review of regulatory submissions.
• Coordination for cGMP Training activity including training of identified people.
• Review and approval of Artwork / Labelling.

Qualification & Expeirence

• Postgraduate in Pharmacy
• Experience
• 10 years in Pharma industry with awareness of Quality management systems, Analytical testing, Method Development/Validation, Manufacturing activities, Process validation, Qualification, Regulatory requirements.