QUALITY INSPECTIONS SPECIALIST

FAMAR is a European contract manufacturing and development partner for the pharmaceutical and health & beauty industry. Building on our 70 years’ expertise, we deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1850 employees and with a network of 6 production sites, we supply a wide range of 1800 products in 125 international markets.

We are currently looking for an enthusiastic and committed professional to fill the position of Quality Inspections Specialist.

QUALITY INSPECTIONS SPECIALIST

(QIS_12.2023)

About the Role:

The Quality Inspections Specialist position holder will ensure the implementation of an integrated system on inspections as to continually monitor the implementation of the applied Quality Management System and legislative requirements in an efficient manner for the business.

Location: The position can be at any location in Greece, where the FAMAR Group Quality Function has presence: Alimos, Anthoussa or Avlona.  

Main Responsibilities:

The Quality Inspections Specialist will be responsible for the overall coordination of the Inspections Program Surveillance at FAMAR Group level with the continuous planning, monitoring and controlling of the assigned GxP inspections.

More specifically, the main duties include the following:

• Ownership of the Group Annual Inspections Plan issuance and follow up.
• Ownership of the Group Monthly Flash Inspections Plan issuance and follow up.
• Review of inspection reports as to ensure their consistency and harmonization.
• Build and maintenance of databases for observations assigned.
• Follow up in due time the delivery of inspection reports and the review of submitted CAPA plans.
• Establishing and maintaining Key Performance Indicators for inspections.
• Maintain the current Qualified Inspectors List.
• As member of the Group Quality Function, the position holder will contribute to the following:
  • Training delivery of the assigned sessions, as per area of expertise.
  • Authoring and/or reviewing of Quality Systems Procedures.
  • FAMAR Quality System as applicable by opening, reviewing and/or approving relevant records (e.g. Deviations, CAPAs, Change Controls).

Profile, Skills, Qualifications:

General Qualifications:

• Scientific University Degree in Chemistry, Chemical Engineering, Pharmacy or Biology.
• Minimum 3 years’ experience in Quality management within the pharmaceutical / healthcare industries (CDMO experience preferred).
• Must be fluent in English (advanced verbal and written skills). Knowledge of the Greek, Italian and/or Spanish languages will be considered an advantage.
• PC literacy (excellent MS skills- especially Word, Excel, PowerPoint).

Technical Qualifications:

• Experience in Electronic Quality Management Systems (eQMS), Document Management Systems (eDMS) and Electronic Inspections Management Systems will be considered an advantage.
• Current knowledge of both theoretical and practical aspects of EU and US Regulations and Directives, Quality Management Systems and processes (ISO 9001, ISO 13485, ISO 22716), as well as comprehensive knowledge of international GMP regulations.

Personal Characteristics:

• Excellent interpersonal skills and written / verbal communication.
• Soft skills on change management, time management, listening, autonomy, self-confidence, problem solving, results orientation, ability to work under remote management.
• Ability to travel at 30% of time in both domestic and international travel.