QA External Contract Laboratories Specialist Full

1 settimana fa

Latina, Italia amaris A tempo pieno

Job description

We have another opportunity in the Pharmaceutical world

**The role we are seeking**:
The QA External Contract Laboratory Specialist will be responsible for ensuring the quality and compliance of pharmaceutical products through effective management of external contract laboratories. The role requires a strong background in pharmaceutical QC, QA, and GMP, with a focus on maintaining high standards of quality through collaboration with internal and external stakeholders. The specialist will also be involved in data review, quality records review, CoC assessments and support for internal stakeholders ensuring adherence to global GMP requirements.

What will you do?

Plan and manage interactions with internal and external stakeholders to ensure
the timely approval of Quality Agreements with contract laboratories.
Collaborate with stakeholders to optimize processes and maintain high-quality
standards.
Work with internal and external stakeholders to identify and implement process
improvements within the scope of quality control and assurance.
Support the review of data and quality records related to audits, CAPAs, and
other quality requests from internal stakeholders.
Ensure that all data and records adhere to the required quality standards and
are compliant with GMP regulations.
Provide support for internal assessments and CoC assessments to ensure compliance
with quality standards and regulatory requirements.
Maintain effective communication with internal teams and external contract
laboratories to facilitate quality assurance processes.

✍️ What do we require?

Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field; advanced
degree preferred.
Proven experience in
pharmaceutical Quality Control (QC) and Quality Assurance (QA).
Strong understanding of
global Good Manufacturing Practices (GMP) requirements.
Advanced proficiency in English (Level C1), with the ability to communicate clearly and
effectively in both written and spoken forms.
Proficiency in using quality management systems and software.
Ability to manage tasks and timelines effectively.
Strong analytical and problem-solving skills.
Ability to work independently and make informed decisions regarding quality matters.
Detail-oriented with a commitment to accuracy and thoroughness.
Willingness to undergo further training and development as required.

✔️ What do we offer?

Work by objectives with quarterly monitoring.
Educational and technical growth path.
Competitive salary
Inclusive work climate.
Lunch vouchers of €8 per working day.
Free access to Mantu Academy platform with more than 500 courses.
Psychological counseling.

**Pioneer Spirit**: desire to explore new technologies, ideas and skills to build a more sustainable world.

**Care**: commitment to promoting diversity, meritocracy, and environmental protection for a better future.

**Performance**: constant ambition to achieve excellence through creativity, innovation and technology.

**Trust**: trust is a pillar of progress, driving freedom, creativity and innovation.

**Independence**: independence is the basis for realizing a prosperous and agile future.

Amaris Consulting is an industry-leading Top Employer 2024-certified company that supports its partners in the main areas for Pharma and Biomed Industries in Quality, Laboratories, R&D and Production.

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.

**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.

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