Change Control Manager
1 month ago
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Job Objective
Change Control Manager will perform technical management and supervision of change controls,
including changes to processes, systems and technology, work roles, and organization structures,
determining and evaluating the impact of these changes and their implementation on the product
licenses approved by Health Competent Authorities.
Environment
Internal: Quality Assurance, Quality Compliance and Quality Systems, for both Plasma and
Manufacturing Area.
External: Health Authorities, Government authorities and auditors.
Key responsibility
Establish a defined change control process to approve or reject the change and involves
appropriate stakeholders, including but not restricted to Manufacturing, Quality, and Regulatory
Affairs personnel.
Coordinate the reception of change control request and determine the areas involved for further
evaluation by each of them.
Compile global evaluation and determine if there is a Regulatory impact on the Final product
licenses as well as in the licenses of Blood Establishments involved in the change.
Determine data (existing and/or to be newly generated) needed to support the change and
accordingly develop study protocols describing the methods, prospective acceptance criteria as
well as additional post-implementation process performance and/or product quality monitoring
as necessary Control that all the steps to be taken for final implementation have been done
before the implementation.
Ensure implementation by reviewing that the change as implemented remains aligned with the
relevant study protocols, and relevant documentation and perform an assessment of data
generated to demonstrate that the change objective and acceptance criteria were met.
Provide guidance to Quality specialists under his/her responsibility.
Academic experience required
Bachelor ‘s Degree in Health-related Sciences.
Post-Graduate Certification in Quality Management.
Knowledge of cGMP requirements preferred.
Professional experience required
Minimum of 4 years of Management or technical leadership experience is required.
Minimum of 6 years of related experience in Change Controls field in Pharmaceutical company.
Computing skills
MS Office knowledge.
Personal skills
Organized and able to manage time effectively.
Ability to work within a highly regulated, labor intensive environment.
Ability to understand, explain, follow, and enforce SOPs and protocols.
Ability to plan, communicate and execute activities for the improvement of overall operations.
Strong integrity and commitment to Quality and Compliance.
Ability to work in groups and with other departments.
Excellent oral and written communication skills to produce clear and concise factual findings
and ability to present effectively to groups.
Languages
Written and fluent spoken English and Arabic, preferable.
#LI-MB1
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: EMEA : Egypt : Egypt:EGTOLIP - Tolip El Narges-New Cairo
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