Product Quality Lifecycle Supervisor

Posted 9 Days Ago
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Pallini, GRC
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Lead and oversee product quality lifecycle activities to ensure cGMP compliance and product release. Manage inspections, testing, investigations (OOS/OOT), validations, CAPAs, deviations, audits, documentation, stability and APQR oversight, training, and cross-functional quality integration to continuously improve product quality.
Summary Generated by Built In

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a Product Quality Lifecycle Supervisor to join our Corporate Quality Management team at our Pallini premises.

The Product Quality Lifecycle Supervisor is responsible for ensuring that all products meet the company's quality standards and specifications.

More particularly:

What you’ll do:

  • Collaborate with the quality control team to ensure that all products are tested and meet established quality standards before release
  • Implement and monitors inspection and testing processes to identify and address any deviations from product specifications
  • Lead investigations into product defects, determine root causes, and implement corrective actions to prevent recurrence
  • Identify opportunities for improving product quality and lead initiatives to enhance production processes and reduce defects
  • Ensure all products comply with cGMPs, relevant industry standards and regulatory requirements, to support product release
  • Maintain detailed records of quality control activities and prepare reports on product quality performance for management review
  • Work closely with production, R&D, and supply chain teams to ensure quality standards are integrated throughout the product development and manufacturing processes
  • Provide training to staff on quality standards, and industry best practices
  • Follow Company's Quality Policy and comply with current operational standards and legislative requirements
  • Ownership of activities related with Process Validation, Cleaning Validation, OOS/OOT investigations, various statistical evaluations, various studies, APQR and stability oversight
  • Active participation in SOPs and Master Records preparation/review, Deviation handling, Complaint management, Document Management, Training system, Audit management including Self Inspection, Risk Management, Escalation process, KPIs monitoring, Change Management, CAPAS, Aseptic process Simulation, utilities/environmental monitoring, as well as other Quality Management System policies and site quality operations oversight and Data Integrity Campaign, as well as various transfer and engineering projects

Requirements

The ideal candidate should have:

  • Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
  • Minimum of 5 years of experience in product quality management

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Exceptional communication skills, strong project management skills
  • Broad knowledge and extensive experience on pharmaceutical quality systems Extensive knowledge of European GMPs in order to be able to ensure compliance with national and European standards and legislation
  • Effective problem solver
  • Strong initiative and creativity 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.

Skills Required

  • Degree in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
  • Minimum 5 years experience in product quality management
  • Extensive knowledge and experience with pharmaceutical quality systems
  • Extensive knowledge of European GMPs and relevant regulatory requirements
  • Experience with Process Validation and Cleaning Validation
  • Experience handling OOS/OOT investigations and implementing corrective actions
  • Experience with APQR, stability oversight, and statistical evaluations
  • Experience in SOP and Master Record preparation/review, Change Management and CAPAs
  • Experience in Deviation handling, Complaint management, Document Management and Audit management
  • Knowledge/experience with Aseptic Process Simulation, utilities/environmental monitoring and Data Integrity
  • Experience supporting transfers and engineering projects related to quality
  • Excellent English communication (written and spoken)
  • Computer literacy
  • Strong project management skills and ability to prioritize tasks and meet deadlines
  • Effective problem solving, initiative and creativity
  • Experience providing training on quality standards and best practices
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The Company
HQ: Amstelveen
1,600 Employees
Year Founded: 1969

What We Do

Pharmathen is a research-centered, pharmaceutical company focused on developing and marketing innovative generic products and complex drug delivery technologies, aiming to provide Life Cycle Management solutions.

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