GMP Officer

Job description

Job Description

Responsible for managing, investigation and timely conclusion of deviations, complaints, and other quality events with major or critical impact on patient safety, product quality, or product supply. Represents PU during local and global quality assessments on product quality. Liases with all necessary functions during investigation, e.g. QA operations, QA compliance, PUs, QC, AS&T, TRD, RegCMC, or external supliers. Acts as change manager to increase quality oversight on the shop floor.

• Provides & actively supports the preparation of investigation reports of deviations with major or critical impact on patient safety, product quality, or supply
• Tracks major, critical and recurrent deviations. Trending of major and critical deviations and OOS, reporting to the respective stering committee, and facilitate upper management decision of strategic CAPAs.
• Acts as change manager to increase quality oversight on the shop floor. Facilitates and supports co-location of QA/PU to increase right-first-time.
• Acting as a subject matter expert for data integrity.
• Directs the management of discrepancies in bulk drug product and finished product manufacturing (and if applicable: quality control and complaints) and facilitates investigations to resolve the issue in a timely manner. Implementation of corrective and preventive actions using rapid root cause analysis.
• Uses scientific judgment, a quality mindset and operational experience to ask key questions during investigations intended to identify the root cause
• Challenges PU investigations/decisions to facilitate smooth QA approval process. Improved deviation handling by facilitating PU-QA-interactions.
• Liases with all necessary functions during investigation, e.g. QA operations, QA compliance, PUs, QC, AS&T, supply chain, customer service, TRD, RegCMC, or external supliers
• Defines, implements, and tracks sustainable corrective and preventive actions
• Maintains awareness of current GMP trends regarding manufacturing processes and supports continuous improvement
• Lead teams to provide scientific evaluation of issues to mitigate business and compliance risk as well as maintaining product quality and product supply of pharmaceutical products
• Provides expertise regarding product safety in the context of production discrepancies and status of related change control
• Provides support for internal and health authority inspections and requests
• Represents PU during local and global quality assessments on product quality and recall assessments

Desired profile

Minimum requirements

• MSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.
• Fluent in English and in local language
• Experience in manufacturing/ manufacturing science and technology/technical development/Quality.
• Thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• Expert in reviewing and writing technical reports.
• Experience in IQP techniques (e.g. rRCI)
• Project management experience in a cross-functional environment.