Investigations Manager
vor 1 Woche
Position Overview
">The Investigations Lead position in MSIT focuses on conducting thorough non-conformance investigations to ensure compliance with Johnson & Johnson requirements. As a key member of the team, you will be responsible for leading the investigation process from initiation to resolution, including the identification of root causes, implementation of corrective actions, and verification of effectiveness.
">Main Responsibilities:
- Lead non-conformance investigations, perform impact assessments, and gather data from various sources to prevent recurrences in manufacturing operations.
- Conduct Root Cause Analysis (RCA) to determine the most likely cause of non-conformances, identify corrections, and implement preventive actions.
- Collaborate with Operations, Quality Control, Quality Assurance, and other departments to communicate investigational status, facilitate reviews, and resolve comments.
- Develop comprehensive investigation reports that accurately capture immediate actions, containments, conclusions, and follow-up actions to prevent recurrence.
- Work on the manufacturing floor with SMEs to gather data, observe processes, and conduct interviews.
- Facilitate meetings, align internal and quality review teams, and engage subject matter experts to drive investigational progress.
- Manage multiple quality investigation projects and timelines concurrently, adhering to standard timelines and escalating actions as needed.
- Contribute as an SME in assigned tasks and processes beyond lead investigations.
- Provide input on validation and qualification assessments.
- Represent the team during audits and health authority inspections.
Requirements:
- Bachelor's or advanced degree in Chemistry, Biochemistry, Pharmacy, or a relevant scientific discipline.
- 3+ years of experience in biopharma production environments regulated by cGMP standards, preferably in manufacturing operations and/or Quality Control.
- Proven skills in supporting pharma process investigations, Root Cause Analysis tools, and technical writing.
- Strong analytical thinking, problem-solving attitude, and teamwork capabilities.
- Excellent complex conflict resolution, problem-solving, and project lead experience.
- Proficiency in Excel and ability to prioritize multiple assignments and changing priorities.
- Language Requirements: Proficiency in English is required; German language skills are desirable but not mandatory.
About Us:
Randstad Inhouse Services offers a dynamic and collaborative work environment, where you can grow your career and contribute to the success of our clients. We are committed to providing excellent service and value to our customers, and we strive to create a positive impact in the communities we serve.
Salary Estimate:
Based on industry standards and location, the estimated salary range for this position is approximately CHF 80,000 - CHF 110,000 per annum, depending on qualifications and experience.
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