Quality Assurance Manager
: Job Details :


Quality Assurance Manager

Tjoapack

Location: Clinton,TN, USA

Date: 2025-01-09T04:23:56Z

Job Description:

Position background

In the role of Quality Assurance Manager, you'll assume responsibility for overseeing the quality of our products and services. The activities encompass monitoring quality through visual, physical, or microbiological controls, as well as data verification. Please note that this is an onsite role, and you will be required to be present at the location five days a week. Within this QA team, there are five primary focus areas:

  • Assessing incoming release of bulk products and components
  • Reviewing batch records, including pre and post-production checks
  • Handling deviations and complaints
  • Managing Product Quality Reviews (PQRs)
  • Continuous improvement projects including change management

Your role involves managing resource allocation according to business needs and collaborating with stakeholders such as Operations to address quality and compliance issues. This includes managing deviations, change controls, complaints, and Corrective and Preventive Actions (CAPA). In this role, you will report to the Director of Quality.

Your responsibilities

As Quality Assurance Manager, you will be instrumental in developing, implementing, and maintaining quality assurance policies and procedures to ensure compliance with all relevant standards and regulations. You will manage and lead a team, fostering a culture of excellence and accountability. Your ability to drive change management initiatives will be crucial as you collaborate closely with operations to resolve quality and compliance issues, taking the lead in various investigations as needed. Below are the responsibilities include:

  • Oversee the incoming release of bulk products and component assessments.
  • Conduct thorough reviews of batch records, managing pre and post-production checks.
  • Lead the management of deviations, complaints, and Product Quality Reviews (PQRs).
  • Spearhead continuous improvement projects and change management initiatives.
  • Conduct regular audits, self-inspections, and Root Cause Analysis (RCA).
  • Manage and resolve customer complaints, implementing effective corrective actions.
  • Foster a team-oriented environment that supports learning and continuous improvement.

Our offer

We will help you become successful in your new job with a customized development plan. At Tjoapack, we work hard, encourage innovative ideas, and give freedom to work independently.

Place within the organization

Tjoapack is a global contract packaging organization (CPO) specialized in primary and secondary pharmaceutical packaging and supply chain management services. We're dedicated to shaping the future of the pharmaceutical supply chain to be safer and more reliable for our customers and for patients. With more than 30 years of track record in contract packaging, we use our knowledge and experience to offer flexible solutions to our customers challenges and use the latest technologies to continuously improve our operations. We now supply products to over 45 countries across all continents.

As the Quality Assurance Manager, you'll be part of the Quality Unit, which is at the heart and head of our total quality vision and mission. It is the Quality Unit's responsibility to make sure that our people, processes, materials and machines work together to assure patient safety. You will report to the Director Quality Assurance.

A TMA Analysis is part of the selection criteria.

Your letter of motivation should be in English. Please address your letter and CV to Samira Houdane, Corporate Recruiter, and use the apply button.

Your background, qualification and skills

  • Master's degree in a technical or scientific field, or Bachelor's degree with relevant work experience.
  • Proficiency in pharmaceutical environments, particularly Good Manufacturing Practice (GMP).
  • Strong track record in investigating and resolving complex issues, utilizing methodologies such as root cause analysis.
  • Exceptional decision-making abilities with a focus on risk management, including familiarity with tools like FMEA.
  • Proven leadership skills in guiding teams and individuals towards growth and professional development.
  • Experience in planning, scheduling, and monitoring work to meet quality and time targets.
  • Proficiency in utilizing data for optimization projects.
  • Possess a continuous improvement mindset, preferably with Lean Six Sigma green belt certification or equivalent experience.
  • Customer-oriented and service-minded approach.
  • Effective communication skills across various levels and departments, both internally and externally.
  • Experience with Tableau is advantageous.
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