Quality Analyst Associate

Overview

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Descrição da Função: Join a leading pharmaceutical company and play a key role in ensuring the highest standards of quality and compliance. As a Quality Analyst Associate, you’ll contribute to processes that make a real impact on people’s lives, working in an environment that values innovation, integrity, and continuous improvement. Take this opportunity to grow your career with a global industry leader!

Responsibilities

• Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and/or products in accordance with applicable c
  GMP, quality operational standards/procedures and legal regulations, ensuring the site is always “audit ready”.
• Promote the importance of
  - quality levels and the importance of a continuous improvement culture in relevant company activities.
• Act as a catalyst for change and improvement in performance/quality.
• Manage assigned projects related to areas such as Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR.
• Provide professionalism and support inducting and training new colleagues within the area.
• Ensure project/product activities are delivered in compliance with c
  GMP and maintain the company Quality Management System.
• Manage and participate in Quality Product key activities for the assigned product/projects, including preparation, review and approval of auxiliary documentation, protocols and
  - related reports.
• Prepare for and support internal and external site audits and inspections, conduct regular reviews, and follow up action plans as necessary.
• Ensure inspection readiness in completed work and act in an advisory capacity for all internal and external site audits.
• Follow up of ongoing deviations and Pd
  As to assure timely closure and approval as appropriate; close open deviations and propose CAPAs based on
  - up outcomes.
• Prepare SOPs, department IOPs,
  - related reports, revision of batch documentation and change control documents (Pd
  As) as required; approve IOPs, process master documentation and product specifications as required.
• Ensure SOPs and IOPs are up to date, compliant and support efficient production.
• Review regulatory documentation and coordinate site documentation to support regulatory requirements.
• Authorize the usage of production equipment/utilities when qualification is required.
• Solve compliance challenges by providing collaborative and timely support to all areas and departments, escalating as required.
• Ensure effective and proactive flow of information between stakeholders, representing the team as appropriate.
• Promote compliance on Health, Safety and Environment in the area and activities for which is responsible or participates.
• Maintain a regular presence on the manufacturing floor, providing
  -
  - job support and developing collaboration with operational areas.
• Approve Validation Master Plans, Process Validation Protocols and reports as required.
• Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area.
• Coordinate and assist with the analysis and investigation of customer complaints to ensure they are investigated and closed within specified timeframes.
• Provide relevant training to new colleagues and other areas in applicable c
  GMP, internal procedures and quality systems in accordance with established training plans.
• Be an advocate for safe operating and
  - quality performance, alerting colleagues to potential risks or
  - conformances and suggesting optimizations or improvements as needed.
• Plan and deliver all assigned tasks on time, safely, efficiently, reliably and
  - effectively.
• Propose improvements and solve problems within the area and make quality and timely decisions in Quality Assurance tasks.
• Gather relevant data to inform decision makers on complex issues.
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements, and promote the implementation and maintenance of company policies, systems and procedures.
• Undertake any additional tasks commensurate with the role as required.

Qualifications

• University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).
• Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable).
• Experience of working in a GMP operational environment (mandatory).
• Training and experience of GMP standards (mandatory).
• Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable).
• Strong understanding and knowledge of GMP practices.
• Fluency in English is a requirement.
• Computer literate with good working knowledge of the MS Office package.
• Strong documentation skills and attention to detail.

Location

• Loures - Sete Casas, Portugal

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance
• Industries: Human Resources Services

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