Senior Manager QA Biologics | Sun Pharma | Hyderabad

Job Description

Role & Responsibilities:

• Design and implement a quality system that complies with the national and international regulatory and quality standards/ expectations and promotes continual improvement across all key functions within Quality Assurance, Quality Control, and Microbiology to meet current local FDA and US & EU markets.
• Establish the team, provide training, clearly define roles and responsibilities, and closely monitor the implementation of the Quality Analytical system to ensure effective development and commercial manufacturing of finished dosages for Biologics Drug Substances. Preference will be given to candidates with experience in mammalian quality systems, particularly single-use systems
• Keep refining the existing quality system by constant internal assessments and learning through regulatory/Internal/external audits in order to keep up the compliance
• Organize to review the compliance at manufacturing functions for critical quality attributes for process, CGMPs, analytical, and facility.
• Organize Management Review Meetings and be an active reviewer and coordination for product quality, development, and regulatory strategies, critical quality issues, etc.
• Plan and closely monitor the training activities for Quality and other cross functions.
• To ensure that objectives of Quality Assurance, Quality Control, and Microbiology functions are set in alignment with organizational objectives and complied with.
• Ensure better coordination between organizational functions to achieve compliance and operational excellence.

Qualification: MTech/MSc Biotechnology with 13-17 years of relevant experience

Salary: 15.00-18.00 Lacs CTC/PA

Division: Zenotech (Subsidiary of Sun Pharma)