Job description
Main tasks:
- Design and Development for Pharmaceutical and Non-active Medical Device (NAMD):
o Works as part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients as well as regulatory and corporate SOP compliance.
o Reviews and approves design and development deliverables along the product development process as well as design changes.
o Reviews and approves Technical Reviews, Design Reviews and Phase Exit Reviews.
o Reviews and approves Design Transfer and Technology Transfer Plans, Checklist / Reports.
o Guides engineering teams through the product development and design change process in a compliant and efficient way.
o Reviews and approves registration relevant lab documentation and product development deliverables
o Provides training on Design & Development relevant quality requirements. - QMS for Pharmaceutical & Non-active Medical Device:
o Support local process owner to create / update local QMS documents.
o Create / update local QMS documents.
o Review local QMS documents. - Sterile Fluids Lab Management:
o Support quality supervision of the pharmaceutical & NAMD lab management.
o Review and approve lab management records, include but not limit to instrument / equipment, computerized systems, materials, reagents, reference standards. - Deviation, Nonconformity (NC) /CAPA:
o Provide inputs on the deviations, NCs / CAPAs from quality and regulatory perspective, review corresponding records for Design & Development, lab operations.
o Acts as quality approver of deviations, NCs / CAPAs.
o Acts as a Quality Assignee for system / processrelated topics. - Audit:
o Support facilitators for internal and external audits.
o Acts as an auditee for design & development relevant chapters - Lab Investigation:
o Provide inputs on Out of Specification (OOS), Out of Trend (OOT) and Out of Expectation (OOE) lab investigation from quality and regulatory perspective, review corresponding records.
Reqirements:
- Bachelor’s or Master’s degree in pharmaceutical area.
- 3 or more yeas’ experience of quality assurance.
- Application of Design Control, Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO 13485, ICH guidelines, Pharma GMP, IEC 60601 and ISO 14971 Risk Management
- Experience with product or process design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding
- Must possess an intimate understanding of Design Controls and solid engineering expertise enabling them to guide the development of new products and design changes
- Experience with development of design input and traceability through verification and validation V&V activities
- Experience with identification of relevant compliance standards and associate testing
- Demonstrated presentation and communication skills
- Fluent speaking and writing skills
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.
Who are we?
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 7500 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.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!