Job Description

• 🎯 Purpose
• Ensure that cleaning procedures and process validation activities are properly prepared, executed, and documented to maintain compliance with regulatory standards (e.g., GMP, FDA, EMA) and internal quality systems.
• 📌 Key Responsibilities
• Cleaning Validation Activities
  • Develop and maintain cleaning SOPs and protocols.
  • Prepare cleaning schedules and ensure availability of required materials, equipment, and detergents.
  • Conduct risk assessments for cleaning procedures.
  • Coordinate with production teams to minimize downtime during cleaning.
• Process Validation Support
  • Assist in drafting and reviewing validation protocols (IQ/OQ/PQ).
  • Collect and analyze data during validation runs.
  • Support qualification of equipment and utilities related to process & cleaning validation.
  • Ensure compliance with regulatory guidelines and internal validation master plan.
• Documentation & Reporting
  • Maintain accurate records of cleaning and validation activities.
  • Prepare summary reports and deviations.
  • Provide all time supports in audits and inspections with providing documentation as required.

Qualifications

• Bachelor’s or Master's degree in Pharmacy, or related field.
• 2–5 years of experience in cleaning validation or process validation (preferred).

• Training in GMP compliance and validation practices.

  🧑‍💼 Skills & Competencies

• Strong knowledge of GMP, GLP, and regulatory requirements.
• Familiarity with cleaning validation techniques (TOC, HPLC, swab/rinse recovery).
• Attention to detail and strong documentation skills.
• Ability to work cross-functionally with production, QA, and engineering teams.
• Analytical and problem-solving mindset.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.