QUALIFICATION & VALIDATION OFFICER

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 seeking to recruit for Anthoussa BU:

QUALIFICATION & VALIDATION OFFICER

SUMMARY:

The position holder will be responsible for supporting the BU in (re)qualification , validation and calibration activities. The position is reporting directly to the Qualification / Validation / Calibration Manager of the site.

Main duties & responsibilities:

• Provide and execute Installation Qualification (IQ), Operational Qualification (OQ) protocols, Calibration protocols


• Prepare and participates in Audits, in his/her area of responsibilities and providing the information requested.


• Responsible for the issuance and the proper execution of Calibration Master Plan, including communications required with external sub-contractors and involved departments.


• Generate base level documents such as URS and SOPs in support of qualification / calibration activities.


• Provide any assistance required for the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.


• Initiation of change controls and deviations related to validation/calibration activities


• Prepare and ensure all necessary procedures for Startup of the site.

Candidate profile

• Bachelor’s degree in engineering field


• At least 2 years of validation/calibration experience in the pharmaceutical Industry and GMP environment.


• Experience in participation in GMP audits


• Excellent knowledge of English language (oral/written)