Senior Associate Manager Quality ( Microbiologist)

Client of Anzaa Consultants

Key Responsibilities:

Laboratory Operations:

• Conduct and train team members on microbiological inspection and testing of raw materials, intermediates, and bulk products.
• Perform annual product reviews, Preservative Efficacy Testing (PET), and Product Compatibility Testing (PCT).
• Conduct culture isolation and identification for quality monitoring.
• Ensure adherence to laboratory safety protocols and documentation standards.
• Execute OQ/IQ/PQ method validations, and lead the commissioning of new laboratory and production equipment.
• Manage lab batch preparation, stability studies, and related documentation.
• Coordinate and support technology transfer activities across production units.
• Prepare and maintain product dossiers and technical documentation as per regulatory and company requirements.
• Perform lab batches/ stability samples.
• Lead new product trials, troubleshooting initiatives, and process modifications.
• Coordinate technology transfer activities across production units
• Knowledge on making product dossier.

Validation:

• Lead and manage process, cleaning, method, and equipment validation activities in coordination with cross-functional teams.
• Develop and review validation protocols and reports in compliance with GMP and global regulatory requirements.
• Ensure periodic requalification and revalidation as per schedule.
• Participate in validation-related risk assessments and implement CAPAs effectively.

R&D and New Product Development:

• Collaborate with the R&D team to support new product trials, scale-up, and formulation transfer to production.
• Provide quality inputs during formulation design, packaging compatibility, and stability evaluation.
• Participate in troubleshooting and process optimization initiatives for new and existing products.
• Ensure R&D documentation aligns with regulatory and quality system requirements.

Audit & Compliance:

• Coordinate and support internal and external audits, including ISO 9001, 14001, 45001, HACCP, BRCGS, ISO 22716, SEDEX, and HALAL certifications.
• Ensure compliance with Good Manufacturing Practices (GMP) and all applicable regulatory standards.
• Monitor and maintain supplier documentation, ensuring quality alignment across the supply chain.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance product quality, process efficiency, and cost optimization.