[Two Bee]

Tirane

Nr. Njesia - Zona me e afert?

3 Xhamlliku | Oxhaku | Profarma

Tipi

1. me orar te plote

Fusha | Profili i punes

1. Farmaceutik

Gjuha

1. anglisht

Eksperienca

vetem me eksperience

Position: Quality assurance

Major tasks and responsibilities (as permanent function on site):

• Develop and keep up to date quality standards; ensure an efficient and solid implementation of a “quality based” organizational process meeting both GMP and company quality requirements at the most stringent level
• Monitor and review all production, quality control, analytical support, stores & distribution, product development, and engineering operations to assess ongoing GMP compliance and quality of released pharmaceutical processes/products
• Review validation/stability reports to ensure that all information contained within, is correct and accurate
• Unlimited access to company department processes to check compliance with established and approved cGMP rules and enforcing quality standards
• Prepare statutory / regulatory and client inspections ensuring that all concerned people in the organization are prepared to pass successfully through inspection and coordinate directly or indirectly the resolution of all deviations
• Assist all departments in the implementation of quality systems, including CAPA management, change controls and risk assessments
• Ensure that quality systems are continuously improved with the objective of assuring the GMP compliance and quality of pharmaceutical products
• Act as internal and external contact for questions concerning product compliance and quality
• Assist in monitoring and reviewing quality system elements such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports, with the objective of assuring the GMP compliance and quality of pharmaceutical products
• Carry out internal audits as applicable
• Support procurement in compilation of technical agreement for materials and engineering items
• Develop proper qualification / requalification strategy for the site covering design, assets installation, operation and maintenance and secure that all departments/disciplines obey to them

Requirements

• University degree in scientific disciplines with several years of professional work experience
• Robust and proven knowledge of EU guidelines regarding GMP
• Proficient in writing, reading and editing technical documents, protocols and reports
• Proficient in use of Microsoft office products for means of creating and conveying technical information and presentations
• A very skilled leader, with the understanding of how to develop bridges between disciplines, the person in this role will be a credible discussion partner for upper management and internal/external business leaders. The person will be able to demonstrate a pro-active approach in staying up to date with industry trends and developments.
• Product and Process Development Experience (desired)
• Attention to details
• Ability to work under pressure
• Customer focus; ability to deal with ambiguity and conflicts
• Languages: English and preferable even Italian

info@fufarma.al