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 analyse 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
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.
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.
