Within this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of Manufacturing logbooks.

As a Supervisor Manufacturing Support, a typical day might include but are not limited to, the following :

Co-ordinating preparation and reporting of key metrics

Driving right first-time completion of manufacturing batch records and timely review and close out of all manufacturing documentation

Reviewing and editing batch records in accordance with cGMP standards

Facilitating and cataloging Manufacturing Records, Batch Sheets & Cleaning Verification sample packs

Serving as a liaison between manufacturing and other functional areas as needed

Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.

Schedules individual and ongoing training

Ensuring safety standards are maintained at all times

Supervising a team responsible for the co-ordination of manufacturing record review, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of Manufacturing logbooks in a cGMP regulatory environment

This role might be for you if :

You have experience in Technical writing and review of deviations / reports

You possess logical troubleshooting and problem-solving skills

You have excellent analytical, written and oral communication skills

You demonstrate an ability to work within a successful team

Requires BS / BA in Life Sciences or related field with 5 years of relevant cGMP manufacturing experience and some previous supervisory / leadership experience along with Technical writing and review of deviations / reports or equivalent combination of education and experience.

REGNIELSM #LI-Onsite

Last updated : 2024-04-06