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Center Quality Specalist - Banha at GRIFOLS, S.A.

Banha, Al Qalyubiya, Egypt -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SOP Development, CAPA Management, Change Control, Quality KPIs, Regulatory Compliance, cGMP, Quality Auditing, Plasma Collection Oversight, Complaint Management, Annual Quality Reviews

Industry

Pharmaceutical Manufacturing

Description

KEY RESPONSIBILITIES : Development, review, revision and implementation of SOPs as required. Manage and evaluate (trending) complaints, deviations, Corrective Actions and Preventative Actions (CAPAs), and Change Control requested. Develop a system of control through main Quality KPIs. Assist Regulatory projects that involve QA oversight. Annual Quality reviews for compliance with Egyptian registration and licenses approved by Health Competent Authorities. Monitor QA aspects of Plasma Collection, warehousing, Testing and shipping practices for compliance with Egyptian Regulation and with Product licenses approved. Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations ACADEMIC EXPERIENCE REQUIRED : Bachelor s Degree in Health-related Sciences. Post-Graduate Certification in Quality Management. Knowledge of cGMP requirements preferred PROFESSIONL EXPERIENCE REQUIRED : Typically requires a minimum of 3 years of related experience. Blood banks or Pharma background preferred.

Responsibilities

Develop and implement SOPs while managing complaints, deviations, CAPAs, and change control processes. Monitor quality aspects of plasma collection and warehousing to ensure compliance with Egyptian regulations and product licenses.