Senior Manager

4 days ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time US$ 90,000 - US$ 1,20,000
Job Title:
Senior Manager - Quality Assurance and Compliance
About the Role

The Senior Manager - Quality Assurance and Compliance will be responsible for leading QA oversight, analytical process development, and tech transfer. This role ensures compliance with GMP, GLP, ICH, and global regulatory standards.


Key Responsibilities
  1. Lead QA Oversight: Oversee the quality assurance function to ensure that all processes are in compliance with regulatory requirements.
  2. Analytical Process Development: Develop and implement analytical methods to support product development and manufacturing.
  3. Tech Transfer: Ensure seamless transition of products from development to production.
  4. Regulatory Compliance: Maintain up-to-date knowledge of relevant regulations and ensure compliance with GMP, GLP, ICH, and global regulatory standards.
  5. Review and Approval: Review and approve development protocols, validation reports, and CMC documents.
  6. CAPA and Deviation Management: Manage CAPAs and deviations, ensuring timely resolution and implementation of corrective actions.
  7. Audit and Inspection Support: Support audits and inspections, including preparation of documentation and responses to questions.

Requirements

To be successful in this role, you will need:

  • Strong Leadership Skills: Proven ability to lead cross-functional teams and drive quality culture.
  • Excellent Communication Skills: Ability to effectively communicate with stakeholders at all levels.
  • Regulatory Knowledge: In-depth understanding of GMP, GLP, ICH, and global regulatory standards.
  • Analytical Skills: Strong analytical skills, with ability to develop and implement analytical methods.
  • Problem-Solving Skills: Proven ability to analyze problems and develop effective solutions.

Benefits

We offer a competitive salary and benefits package, including:

  • Opportunities for Professional Growth: We invest in our employees' development and provide opportunities for career advancement.
  • Collaborative Work Environment: Our team is dedicated to delivering high-quality results and supports each other's success.
  • Recognition and Rewards: We recognize and reward outstanding performance and contributions.

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