QA RA Manager

Deputy Manager Quality Assurance

Responsibilities:

• Lead QMS planning and implementation to ensure regulatory compliance and adherence to Acharya Group standards.
• Review and approve SOPs for Quality Management Systems, ensuring clarity and best practices in API manufacturing.
• Oversee document control for SOPs and BPCRs, maintaining accurate records.
• Train plant employees on quality procedures specific to API production.
• Review annual trending of products and intermediates to verify process and quality system consistency.
• Assist in implementing cGMP guidelines across the Acharya Group.
• Conduct validations (Process, Analytical Method, Cleaning) as per the Validation Master Plan for robust API manufacturing.
• Establish and maintain equipment calibration and validation procedures.
• Conduct vendor and internal audits to assess compliance and identify areas for improvement in the API supply chain.
• Ensure thorough investigation, resolution, and documentation of critical deviations, implementing effective CAPA measures.
• Conduct vendor and internal audits to assess compliance and identify opportunities for improvement within the API supply chain.
• Manage material and vendor quality, including handling audits by USFDA, EDQM, and customer audits.
• Review batch production and laboratory control records before releasing APIs and intermediates.
• Perform periodic product quality reviews and conduct quality risk analysis for continuous improvement of API manufacturing.

General Expectations and Past Experiences:

• Possess a strong understanding of cGMP regulations and guidelines related to API manufacturing.
• Demonstrated experience in managing and leading quality assurance activities in a pharmaceutical setting.
• Proven ability to conduct and manage process validation, analytical method validation, and cleaning validation.
• Experience in preparing and reviewing regulatory documents such as DMF/ASMF.
• Proficient in using Quality Risk Management (QRM) tools and techniques.
• Excellent technical writing and documentation skills.
• Strong leadership and communication skills, with the ability to effectively interact with cross-functional teams and regulatory agencies.