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Qualified Person - Quality

Date: Oct 10, 2021

Location: Baldoyle, IE, D13

Company: Teva Pharmaceuticals

Who Are We

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

We would like to invite applications for the role of Qualified Person (QP) at our Baldoyle site. As Qualified person, you will perform key Quality responsibilities with respect to certification of batches of medical products prior to release for sale or distribution, including Medicinally Licensed over the Counter products as well as third party manufactured medicinal products

The role will also provide release support for cosmetics and Medical Devices as required, staying current with proposed and implemented regulations, and understanding industry trends. As QP you will Interface and collaborate with corporate and functional area management to ensure systems utilised for quality oversight and management are compliant and consistent with Teva Corporate standards to maintain the site’s inspection readiness status

 

A day in the life of our Qualified Person - Quality

  • Act as Qualified Person for release of products in accordance with article 51, EC directive 2001/83/EC
  • Act as QP representative for regulatory inspections where necessary. Where appropriate ensure all relevant manufacturing licenses are maintained
  • Participate in Continuous Professional Development (CPD) initiatives with a view to maintaining, developing and broadening knowledge and skills as they relate to the function of Qualified Person. (Including presentations, tutoring, workshops, self-learning, reading, formal academic education etc.)
  • Review deviation reports including all associated CAPA’s and investigations ensuring that any deviations or planned changes with a potential to impact the product have been authorized
  • Participation of deviation investigation where deemed appropriate
  • Ensure any changes requiring variation to the manufacturing authorisations (MIA) have been notified and authorized by the relevant authority
  • Ensure each batch certified and its manufacture complies with the provisions of the marketing authorisation. Ensure all necessary checks and tests are adequate and performed correctly
  • Maintain a register (or equivalent document) as a record of product batches certified by the Qualified Person prior to release
  • Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate
  • Conduct internal audits of various departments as appropriate to support Inspection readiness
  • Participate in regulatory, corporate and customer audits of sites when required

 

Who we are looking for

Are you….

  •  Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by E.C. Directive 2001/83

Do you have….

  • Proven experience within the Pharmaceutical industry in a leading QA/QC/Compliance role. Broad Knowledge of Analytical Techniques and Experience in HPLC
  • Excellent knowledge of regulations and sources of regulatory information.
  • Experience of creams and ointments manufacture would be an advantage
  • Understanding of Production and Laboratory systems to effect judgement decisions consistent with business needs.
  • Strong Team Building and Communication skills
  • Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence.
  • An understanding of internal/external customer requirements and an ability to respond promptly to needs.
  • Ability to work on own initiative to meet and exceed business objectives

 
 
 

Teva’s Equal Employment Opportunity Commitment

At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.

Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That’s why we’re constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice