Validation Specialist At Minapharm Pharmaceuticals
About the job
About Minapharm:Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
Our Values:
Diversity & Respect
Integrity & Accountability
Collaboration
Leadership & Empowerment
Innovation & Continuous Learning
About The Job : “ Validation Role”
Perform all validation activities related to premises, equipment & utilities qualification, calibration and computerized system validation. Oversight site compliance with data integrity to execute qualification and validation for all manufacturing and cleaning procedure.
Responsibilities
Technically, Execute, rite Validation and qualification Documents (Risk Assessment, Qualification Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report) and SOP’s
Perform & follow up overall qualification/validation activities include (HVAC, UDAF, Incubators, Equipment qualification, Compressed air Qualification, Steam Qualification and water station Qualification etc….).
Technically write calibration Plans and follow up the implementation.
Provide inputs to and administration of the site master validation program as well as assist in maintaining the site validation master plan.
Develop validation policy with roles and responsibilities.
Review/assess proposed changes to qualified equipment via CAPA, change control and work orders to identify requirements necessary to maintain validated status.
Perform computer system validation across the facility related functions including (laboratory equipment and system, engineering utilities, production machines)
Develop and execute validation protocols for equipment and systems in the pharmaceutical industry.
Oversee risk assessments related to validation and qualification activities.
Collaborate and organize with cross-functional teams to implement validation strategies.
Follow up implementation of maintenance procedures, calibration procedures, and other instrument support documents.
Follow equipment calibration plan and coordinate with concerned departments to perform qualification/ validation activities.
Witness equipment qualification/ calibration activities and review qualification documents and calibration certificates supplied by external service providers.
Prepare protocols, execute qualification protocols and report outcomes for process and cleaning validation in addition to Equipment / Utilities qualification.
Issue new SOPs and revise SOPs as requested.
Record incidents, deviations, changes and participate in the investigation and assessment.
Implementation of CAPA, additional controls, change control actions, annual report actions, management review actions
Execute quality risk management projects, health and safety risk assessment and environmental aspects & impacts.
Perform on-site training sessions as relevant.
Requirements:
Specialist: 0 – 3 years in pharmaceutical industry preferably including experience in premises, equipment & utilities qualification and computerized system validation.
Sr. Specialist: 3-6 years.
Education: BSc in pharmaceutical sciences, engineering, computer science or other related disciplines.
Training:
WHO & EU GMP premises, equipment & utilities qualification, calibration and computerized system validation guidelines.
GMP guidelines.
Knowledge:
Basic knowledge of EDA, WHO, ICH, PIC/S & EU guidelines and/or regulations related to premises, equipment & utilities qualification, calibration and computerized system validation.
Basic GMP guidelines.
System Awareness.
Abilities:
Ability to implement and follow-up of validation or qualification requirements.
Ability to evaluate data generated from validation studies.
Proficiency in English language.
Computer literate. (MS Office, Oracle)
Handling multi-tasks in the same time.
High organizational skills.
Behavioral Competencies:
Very good interpersonal skills, critical thinking.
Time Management Skills.
Communication skills.
Analytical skills with attention to details.
Location: 10th of Ramadan " Transportation Provided"