QA Document Controller

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Contingent Worker provides administrative and compliance support to Quality Assurance operations within a multi-product cGxP contract manufacturing environment. The role manages GMP document lifecycle activities in the Documentation Management System, maintains archive records, supports system migration, and processes training documentation. It contributes to daily QA activities by identifying compliance gaps, promoting adherence to cGxP/cGDP requirements, and upholding data integrity standards. Working collaboratively across departments, the position applies analytical and problem-solving skills to support compliance and continuous improvement initiatives as assigned by the supervisor.

Key Responsibilities

• Management of GMP document lifecycle in Documentation Management System including archiving and inactive records
• Management of documents within onsite archive room
• Support DMS Migration activities
• Management of training records including processing and data entries of form
• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
• Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience
• Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections
• Generally provide basic compliance support to staff in all departments
• Demonstrate appropriate interpersonal skills that encourage collaboration of individuals or teams to meet objectives
• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate, identify and improve data integrity process.
• Any other tasks as and when assigned by Supervisor
  

Required Qualifications

• Diploma / Degree in a related Science or Engineering discipline such as Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engineering
• Positive team oriented attitude
• Good communication skills
• Good problem solving and analytical skills
  

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.