Product Quality Operations Officer

Product Quality Operations Officer
Pharmathen, Greece

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Sep 14, 2023
Last Date
Oct 14, 2023
Location(s)

Job Description

We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of hundreds ofcustomers in over 80 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.

Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.

We proudly employ more than 1,350 people from over 24 different nationalities. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision to make a difference in people’s lives through our everyday activities and our products.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Product Quality Operations Officer for the Corporate Quality Management department in our Pallini premises.

As a Product Quality Operations Officer, the ideal candidate will ensure compliance with the GMP standards and ISO requirements by supporting the processes of serialization, codification system, CoA amp; CoC, nitrosamines, elemental impurities, statements, annual product quality review and participating in relevant activities as supply chain flow charts and product profile.

Requirements

More particularly:

What you will do:

  • Support the filling of SAP in the fields relevant to Serialization
  • Participate in the completion of Migration Files
  • Ensure the packaging program both of sites referring to codes
  • Support the filling information in the product profile fields related to CEP, DMF of API, CMOs etc
  • Contribute to the review of Change controls (relevant to API, variations) and any necessary actions relevant to revision of product profiles, serialization, nitrosamines, statements, elemental impurities etc
  • Communicate directly with customers for issues relevant to serialization and the upload of serial numbers
  • Participate in meetings with subcontractors / customers to present the requirements of the company and clarify any points requested as necessary in issues related with the product profile
  • Provide support in the serialization project on quality issues for both production units
  • Handle technical contracts on serialization issues
  • Support the preparation of procedures and technical instructions for the implementation of the serialization project in both of productions units
  • Ensure problem solving in packaging issues related with serialization
  • Collaborate with local authorities for the serialization requirements
  • Participate in the preparation of the supply chain flow charts
  • Contribute to the management of customers’ requests for product quality reviews (PQR), nitrosamines and elemental impurities risk reports and also for the requirement of statements for products relevant to gluten free, halal, alcohol free etc.
  • Support the preparation of the templates for certificate of analysis and conformance for the finished products
  • Participate in the upload of the templates certificate of analysis and conformance in the system LIMS

The ideal candidate should have:

  • Desirable BSc in Chemistry, Pharmacy or equivalent field
  • Minimum of 2 years’ experience in Quality Management or relevant department

Job-Specific Skills:

  • Excellent communication in English language (writing amp; speaking)
  • Experience of working with ERP SAP
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Exceptional communication skills

Benefits

What you'll gain:

  • Involvement in a high-caliber, team-oriented and dynamic atmosphere
  • Exposure to challenging business issues and practices
  • Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Job Specification

Job Rewards and Benefits

Pharmathen

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