Investigation à Allemagne

Job Purpose

The Associate, Quality (Investigations and QA of QC) will be responsible for supporting Quality Assurance activities related to laboratory operation to ensure compliance with cGMP, GLP, regulatory requirements and Sun Pharma internal procedures and processes.

In addition, Associate, Quality (Investigations and QA of QC) is to provide guidance to QC Subject Matter Experts on Out-Of-Specification, Out-Of-Trend and Lab Event records and identification of the root cause, assessment of the associated risks and establishment of the effective CAPAs.

Duties and responsibilities

• Review and Approval of investigations associated with Quality Control functionality such as Out- Of -Specification, Out-Of-Trend and Lab Events to support timely batch release
• Review and Approval of Laboratory GMP documents such as Raw Material, Stability and Finished Good Specifications, Analytical Test Methods, Test Method Validation and Verification and associated reports etc.
• Review of the Compendial method updates
• Ensure identification of the root cause of the issue and execute risk assessments based on the findings of the investigation
• Ensures that all activities related to the recognition, investigation and resolution of investigations are performed in a timely manner and in compliance with the company and regulatory requirements
• Lead Investigator for the Manufacturing Investigations due to OOS in TrackWise
• Assign action items to SME’s ensuring actions are progressing quickly including creation of CAPA
• Obtain and keep current Lead Investigator and Approver certification status as per the Certification Program requirements
• Develop and present critical finding or progress of an investigation to QA Leadership
• Manage extension request and CAPA Effectiveness check in TrackWise
• Identify recurring quality investigations and ensure appropriate actions are taken such as Management notification
• Support the Recall activities
• Other duties as assigned
  
  

Qualifications

• Bachelor's Degree in Science, or related discipline
• Experience with OOS investigations
• Minimum 3 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical industry preferably in handling OOS and non-conformance investigations.
• Good working knowledge of pharmaceutical Quality Systems (ie: Deviations, CAPA, change controls, etc)
• Experience in review and approval of Method Validation protocol and reports
• Sound knowledge and application of Health Canada and FDA regulations
• Capable of leading by influence in matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS), Electronic Documentation Management System (EDMS), and SAP is an asset
  
  

Working conditions

• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail
  
  

Physical requirements

• Hybrid based role (3 days in the office)
• Regular hours are 8:00am to 4:30pm or 9:00am to 5:00pm, with extended hours as required to resolve urgent issues
  
  

Direct reports

N/A