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Posted 8 days ago

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Production Process Specialist

Sapes, East Macedonia And Thrace, GreeceRemoteFull-time

AI Summary

Production Process Specialist at Pharmathen enhances GMP compliance and data integrity in the production department, participates in process validation and batch manufacturing, and oversees production processes for optimization.

About this role

For almost six decades, Pharmathen has remained committed to its vision of improving patients’ lives through innovation and expanding access to complex pharmaceutical therapies.

Today, Pharmathen's capabilities extend across a broad range of specialized dosage forms, including sustained-release products, long-acting injectables, and oral solid dosage forms, while its portfolio includes more than 100 commercial products available internationally through a strong network of partners.

These activities are supported by a robust Research & Development and Manufacturing ecosystem, with three facilities in Greece.

The driving force behind Pharmathen is its people. With more than 1,600 employees representing 27 nationalities, the company fosters a multicultural workplace where women account for 53% of the workforce and 40% of the Senior Leadership Team.

Grounded in its shared values of integrity, quality, innovation, leadership and performance, and guided by strong business ethics and a commitment to its vision, Pharmathen remains dedicated to its founding mission: improving patients' lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a Production Process Specialist to join our team at our Sapes premises

Requirements

More particularly:

What you’ll do:

  • Enhance GMP compliance and Data Integrity and Safety culture in production department
  • Take part in preparation and review of the Production department’s SOPs, process TDRs and other controlled documents of the Quality System
  • Participate and oversight the upscaling, trial and process validation and launch batches’ manufacturing in collaboration with MS&T dpt
  • Oversight, evaluate and interpret of production processes in respect of optimization
  • Handling of Electronic Quality Management System (EQMS) in respect of Production department Quality Records as “Change Control”, “Deviation Management”, “CAPA Management”, “OOS Management” and Training records
  • Participate in Operational Excellence projects and optimization of manufacturing processes

Minimum Qualifications:

  • Minimum an BSc Degree in Chemical Engineering, Chemistry, Pharmacy or relevant field
  • At least 3 years of experience in a pharmaceutical industry

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Excellent knowledge of MS Office
  • Good Technical Writing ability

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

Batch ManufacturingCAPA ManagementChange ControlData IntegrityDeviation ManagementElectronic Quality Management System (eQMS)GMP ComplianceManufacturing Process OptimizationMicrosoft OfficeOOS ManagementOperational ExcellenceProcess TDRsProcess ValidationQuality SystemSOPsTechnical WritingTraining RecordsUpscaling

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