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Senior Manager QC (product Methods & Aliquoting)

Oversee validation and calibration of laboratory instruments to ensure compliance
Kigali City, Rwanda
Senior
3 weeks ago
Biontech

Biontech

Develops mRNA-based immunotherapies and vaccines, notably pioneering a COVID-19 vaccine through advanced biotechnology and translational research.

Senior Manager QC (Product Methods & Aliquoting)

Kigali, Rwanda | full time | Job ID: 10330

Your main responsibilities are:

  • Define (URS) and order the required instruments for the Product testing Unit. (In compliance with company requirements).
  • Issue and update all related SOPs & test methods according to the Guidelines. - Share in the validation and execution of the instrument qualification and validation.
  • Set the schedule and supervise the preventive maintenance and calibrations. (According to the valid contracts).
  • Defining and order the Reference materials, chemicals & miscellaneous requirements for the laboratory.
  • Define the required structure of the Product testing team. - External testing planning and implementation (if required).
  • Responsible for Sampling and Aliquoting Process, making entries in the sample receipt records and planning of sample analysis accordingly. - Responsible for Retention samples/Reference Samples collection and secure storage. - To review the documents related to Product Release.
  • Responsible for reviewing the records of Product Release testing.
  • Responsible for reviewing of validation/qualification protocol, execution of validation activities and review of report of Product testing methods.
  • 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.

What you have to offer:

  • Bachelor's degree of pharmacy.
  • Experience in management of Bulk, Finished Product testing at least 7 years. (Working in sterile manufacturing is a must).
  • Experience in management of stability studies will be added value. - Practical Experience with sampling and Aliquoting.
  • Good Management skills
  • Good Knowledge of Microsoft Office.
  • 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 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.

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Senior Manager QC (product Methods & Aliquoting)
Kigali City, Rwanda
Product
About Biontech
Develops mRNA-based immunotherapies and vaccines, notably pioneering a COVID-19 vaccine through advanced biotechnology and translational research.