Overseeing validation processes, managing laboratory operations, and ensuring compliance with cGMP norms and data integrity standards.
Coordinating validation schedules, reviewing reports, managing deviations, and leading training initiatives.
Issue and update all related SOPs according to the guidelines.
Update the Method of Analysis as per the validation /transfer outcomes.
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.
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 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.

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.

Manager QC – AS&T Validation

Key skills