Associate Manager - Msat (c&q)

Data Science Jobs

Hybrid
Good manufacturing practices compliance
Validation master plans and protocols
Sterile dosage form facility experience
The Associate Manager - Msat (c&q) position at Data Science Jobs is aimed at candidates with extensive experience in quality assurance and validation within the pharmaceutical industry. The role involves evaluating validation processes, ensuring compliance with regulations, and contributing to product development while fostering a culture of innovation and customer orientation

Job Summary

  • This role ensures the delivery of safe and effective products to patients through unwavering commitment to quality and risk-based compliance.
  • The incumbent will evaluate, review, and approve validation master plans while troubleshooting equipment and process validation issues.
  • Candidates must possess strong expertise in Good Manufacturing Practices and familiarity with quality systems such as Change Control and Documentation.

Matching Summary

Match Score: 85

The Associate Manager - Msat (c&q) position at Data Science Jobs is aimed at candidates with extensive experience in quality assurance and validation within the pharmaceutical industry. The role involves evaluating validation processes, ensuring compliance with regulations, and contributing to product development while fostering a culture of innovation and customer orientation.

Skills & Requirements

Must-have

  • Good Manufacturing Practices compliance
  • Validation master plans and protocols
  • Sterile dosage form facility experience
  • IQ OQ PQ protocol execution
  • Change control and deviation investigations
  • DMAIC root cause analysis tools

Nice-to-have

  • Experience with sterile products and medical devices
  • Mentoring and guiding other colleagues
  • Knowledge of generative AI tools like Copilot
  • Strong organizational and time management skills
  • Experience in regulatory audits and compliance

Key Requirements

  • 6-8 years experience in QA/Validation/Engineering
  • B. Pharm, M. Pharm, B.Tech, or BE degree
  • Experience with injectable formulation production
  • Knowledge of GAMP requirements and ISO guidelines
  • Familiarity with 21 CFR Part 11 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter