QA Manager(SAN075)

• QA for Functions will be part of the Internal Quality Operations team, responsible for providing technical support for improvement projects in production facilities.
• This role also involves day-to-day QA operations, such as addressing deviations and changes.

Key Responsibilities

• Support in technical transfer and launch teams (both local and global teams).
• Collaborate on optimization projects for existing equipment, including categorizing URS (User Requirements Specification) and improving equipment related to Data Integrity.
• Manage QA responsibilities for all qualification and validation aspects (QV) of equipment involved in technical transfers and launches.
• Evaluate and approve change requests and handle deviations.

Requirements

• University degree in pharmacy, natural sciences, engineering, or equivalent vocational training, combined with extensive professional experience in the GMP field.
• 3-5 years of professional experience in pharmaceutical production, development, or quality assurance, ideally in aseptic production, packaging, and/or solid dosage form production.
• Experience in qualification and solid understanding of Data Integrity requirements.
• Quick learner with strong affinity for technical questions and GMP compliance, especially regarding validation, equipment qualification, computerized systems validation, and data integrity.

Technical Skills

• GMP
• SOPs
• CAPA
• FDA
• Protocols
• TrackWise

Hiring Team Member

Avula Srivalli

Recruitment Coordinator

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