Job Description
Author, review, and execute Process Performance Qualification (PPQ) protocols and reports in alignment with global standards and regulatory expectations.
Define PPQ strategy including batch numbers, sampling plans, acceptance criteria, and statistical approaches.
Contribute to the development and maintenance of the Process Validation Master Plan (PVMP).
Support lifecycle management changes requiring PPQ, including technology transfers and post‑approval changes.
Develop or participate in risk assessments to evaluate process risks and define appropriate control strategies.
Apply risk‑based approaches to PPQ study design, sampling strategies, and acceptance criteria justification.
Ensure timely closure of PPQ‑related deviations and CAPAs prior to and following PPQ execution.
Maintain accurate and audit‑ready documentation throughout the validation lifecycle.
Work closely with MSAT, Manufacturing Operations, Quality Control, and Quality Assurance to ensure alignment on PPQ strategy, execution, and outcomes.
Ensure all PPQ activities are conducted in compliance with applicable regulations and guidelines.
Support regulatory inspections and internal audits by providing PPQ documentation and technical expertise.
Provide training and technical guidance to operations personnel, validation associates, and cross‑functional team members involved in PPQ activities.
Design and execute Continued Process Verification (CPV) programs.
Hybrid position: 2 days on site.
Qualifications & Requirements
Degree in a science discipline (Chemistry, Microbiology, IT) or Engineering (Chemical, Mechanical, Electrical).
Minimum 3–5 years of experience in pharmaceutical manufacturing, process validation, or quality assurance in a GMP environment.
Hands‑on experience in PPQ design, execution, and reporting.
Proven track record of authoring and reviewing validation documentation (protocols, reports, deviations, change controls).
Experience with risk‑based approaches and statistical methods in validation studies.
Strong communication skills and ability to train cross‑functional teams.
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