Company Description
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses.
With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries.
Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering.
We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential.
Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
About the job
Your role:
- Drive quality culture and promote GMP compliance behaviours to the site.
- Ensure site compliance to Quality Standards and ICH guidelines.
- Provide oversight to the site GMP operations to ensure products produced in compliance.
- Collaborate with cross functional teams to improve quality systems.
- Understand regulatory expectations and support site inspection readiness.
Responsibilities:
- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications.
- Review and approve cleaning records and procedures and ensure compliance with the guidelines.
- Review and approve GMP documentation and ensure their compliance.
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Manage Site change controls and facilitate Change control committee.
- Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact.
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Support internal audits to ensure the internal controls are effective. Support external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues if any.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
About you
- Bachelor’s degree in chemistry or other related scientific field
- A minimum of 2 years of experience in pharmaceutical industry or related industry.
Equal opportunity
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
- Be part of an international, multicultural environment of 7,750 talented people over 60 countries and 5 continents
- Join a fast-growing global group with a turnover of €565M and over 1,000 clients across the world
- Explore opportunities to grow quickly with a tailor-made career path: 70% of our key senior talent joined the company at entry level
- Take advantage of over 500 training courses in our ACADEMY catalogue, which includes programs in interpersonal communication, team management, project management, etc.
- Get the opportunity to support nonprofit organizations thanks to our Foundation initiatives and volunteering platform OneSmallStep
- Depending on your performance and eligibility criteria, you can benefit from international mobility opportunities and progress your career worldwide, and/or experience other departments and sectors
- Unlock your full potential, both professionally and personally.
Apply for QA Consultant (Pharmaceutical).
Job vacancy QA Consultant (Pharmaceutical) and QA Consultant (Pharmaceutical) Salary.
