Preparing and reviewing documents generated by Quality Compliance, as well as continuously following up on CAPAs and commitments made to regulatory authorities.
Conducting & coordinate cGxP training.
Assist in providing regulatory compliance guidance and policies for the company.
Performing other job-related duties as assigned by the direct manager.
Generating, reviewing, and approving Quality Agreements.
Conducting all compliance tasks required for cleaning validation activities and the introduction of new molecules and new equipment.
Handling and hosting external inspections.
Prepare/review the documentation needed for inspections.
Conducting internal (on-site) and external (local suppliers) audits.
Handling internal and external customer complaints and inquiries professionally.
Prepare/review Quality compliance annual product review reports.
Conduct/coordinate internal customers’ annual feedback.
Prepare/review quality risk management reports.
Prepare/review change controls.
Performs other related duties or assignments as directed

2–5 years of relevant experience in the pharmaceutical industry in the QA / compliance field
Bachelor's degree in Chemistry, Chemical Engineering, pharmaceutical Engineering, pharmacy, or related scientific field
Very good English (written and spoken)
Proficiency in MS Office (Word, Excel, PowerPoint)
Familiarity with SAP (preferred)
Knowledge of FDA Current Good Manufacturing Practices (cGMP)
Cleaning Validation Experience is a plus
Lead Auditor certification is a plus
Excellent business communication skills
Strong knowledge of international regulatory requirements (e.g., FDA, EU GMP, PIC/S, SFDA, JFDA)
Computer literacy with demonstrated ability to work with electronic quality systems (QMS tools, Excel‑based trackers, dashboards, Minitab)

Senior Officer, Quality Compliance

Key skills