EDUCATION QUALIFICATIONS

• Minimum bachelor degree in Science, Pharmacy, or related field

EXPERIENCE

• 3-5 years of relevant experience in pharmaceutical manufacturing, particularly in Quality/QMS roles.

SKILLS/ COMPETENCIES

• Knowledge of Good Manufacturing Practices and Good Documentation Practices.
• Ability to have technical writing skills related to QMS documents.
• Ability to work effectively in a cross-functional and cross cultured team environment.
• Self-motivated, with the ability to work independently.
• Strong knowledge of cGMP norms, root cause analysis, CAPA management, and proficiency in QMS software.
• Excellent organizational and analytical skills with the ability to focus on details.
• Experience with QMS Systems (TrackWise) • Basic computer skills (Microsoft Word, Power Point and Excel).
• Shall be abreast of regulatory guidelines such as CDER, CHRA, ICH, USP Monograph, etc.

• Conduct thorough investigations of Out of Specifications (OOS), Out of Trend (OOT), Deviations, including data collection, root cause analysis, complaints and identification of contributing factors.
• Utilize various root cause analysis (RCA) tools (e.g., 5-whys, fishbone diagrams, Etc.) to determine the underlying causes of deviations.
• Maintain detailed and accurate records of investigations, including findings, recommendations, and CAPA plans.
• Work with various departments (e.g., QA, AQA, manufacturing, quality control, engineering, etc.) to gather information and implement CAPAs.
• Implement, and track CAPAs to address the identified root causes and prevent recurrence.
• Effectively communicate investigation findings and recommendations to various stakeholders, including management.
• Maintain detailed records of investigations, CAPAs, and any other related documents.
• Prepare summary data as required and submit to management.
• Other duties [additional support] that management may assign from time to time.