Kigali, Rwanda | full time | Job ID: 10328

About the role:

As Manager QC (AS&T) Validation you will be part of the Quality Control team, and responsible for overseeing validation processes, managing laboratory operations, and ensuring compliance with cGMP norms and data integrity standards. The role involves coordinating validation schedules, reviewing reports, managing deviations, and leading training initiatives to uphold quality and operational excellence.

Your contribution:

• Issue and update all related SOPs according to the guidelines.
• Update the Method of Analysis as per the validation /transfer outcomes.
• Set and algin with concerned parities on the validation schedule.
• Defining and order the Reference materials, chemicals & miscellaneous requirements for the validation processes.
• Define the required structure of AS&T team and build the Job descriptions.
• Build the protocols required for the validation processes.
• Responsible for Sampling and Aliquoting Process, making entries in the sample receipt records and planning of sample analysis accordingly for Process validation/verification.
• Responsible for Retention samples/Reference Samples collection and secure storage for validation batches.
• To review and approve the validation reports.
• Responsible for reviewing the records of validation aspects (raw data).
• Managing deviation, change control, incidences with investigation and associated CAPA.
• Investigation of OOS in the laboratory and associated CAPA with cooperation with the QA department.
• Identify the training need of the staff within the unit.
• To impart and schedule trainings to the subordinates as per requirement in the company.
• To participate in training programs organized by the company.
• To ensure the cGMP norms are followed while performing analysis.
• To maintain the inventories of the lab as per requirement.
• Ensure that all concepts of data integrity are fully respected and followed in the laboratory.
• Ensure and inspect all SHE related topic within the Raw material unit is complying.

A good match:

• Bachelor’s degree of pharmacy.
• Experience in Method Validation, Verification and Method Transfer.
• Experience in Process Validation and Cleaning Validation procedures.
• Good Management of teams.
• Good Knowledge of Microsoft Office.
• Six-Sigma certification. (is Plus)
• Good English communication.
• Background on ERP and LIMS systems Environment.

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘Hire Right’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.