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Manufacturing GMP Subject Matter Expert (SME) (M/W/D)
North Rhein Westphalia, Germany
Currently we are supporting a Drug Substance Biologcs ramp up where we are looking for a SME in GMP to assist the Manufacturing director with all things to do with GMP manufacturing.
The position is based in an agile team that is looking for members that can demonstrate their expertise with promotion opportunities.
Essential Job Functions:
*Set up and organize settled production tasks and assure that the production activities fulfill the current GMP requirements.
*Support team members and ensure trainings have been done and are prepared to perform operations regardless the cGMP regulations.
*Liability on keeping a safe operation environment in cGMP facility and being able to guarantee the safety education and supervision of the team.
*Report the status of process, personnel, safety, environment, maintenance and other issues, on time to the director.
*Responsibility on drafting/upgrading GMP documents, including but not limited to SOP/MBR/URS/FAT/SAT and reviewing batch production records.
*Responsibility in the training or planning of trainings for other employees that might be in need of it, as well as completing personal training tasks on time.
*Set up and organize production process operations, as for example: equipment preparation, medium/buffer preparation, according to GMP regulations.
*Responsibility in the cleaning, disinfection in the clean area answering to the GMP requirements. Periodic cleaning, field cleaning and equipment surface cleaning.
*Support in the investigation of deviation, initiation and execution of change control, and the implementation of the audit rectification activity plan.
*Proactive attitude towards business optimization and improvement.
*Perform other responsibilities assigned by the management
Education:
*Bachelor degree and above in the biology, chemistry, pharmaceutical engineering, other related fields, or equivalent experience.
Experience:
*5 years working experience preferred.
*Relevant knowledge or experience in GMP production operations as well as medium preparation.
*Have excellent problem-solving skills, coordination and communication and management experience.
*Good abilities for planning and execution, analysis and decision making, be able to respond to emergency events.
*Good communication skills both in English and German desired.
*Must work a team member with a positive attitude and good learning ability.
Manufacturing Supporting Team Leader
- Location Germany
- Job type Permanent
- Salary Negotiable
- Discipline Biometrics
- Reference PR/305237_1623656571
North Rhein Westphalia, Germany
Currently we are supporting a Drug Substance Biologcs ramp up where we are looking for a SME in GMP to assist the Manufacturing director with all things to do with GMP manufacturing.
The position is based in an agile team that is looking for members that can demonstrate their expertise with promotion opportunities.
Essential Job Functions:
*Set up and organize settled production tasks and assure that the production activities fulfill the current GMP requirements.
*Support team members and ensure trainings have been done and are prepared to perform operations regardless the cGMP regulations.
*Liability on keeping a safe operation environment in cGMP facility and being able to guarantee the safety education and supervision of the team.
*Report the status of process, personnel, safety, environment, maintenance and other issues, on time to the director.
*Responsibility on drafting/upgrading GMP documents, including but not limited to SOP/MBR/URS/FAT/SAT and reviewing batch production records.
*Responsibility in the training or planning of trainings for other employees that might be in need of it, as well as completing personal training tasks on time.
*Set up and organize production process operations, as for example: equipment preparation, medium/buffer preparation, according to GMP regulations.
*Responsibility in the cleaning, disinfection in the clean area answering to the GMP requirements. Periodic cleaning, field cleaning and equipment surface cleaning.
*Support in the investigation of deviation, initiation and execution of change control, and the implementation of the audit rectification activity plan.
*Proactive attitude towards business optimization and improvement.
*Perform other responsibilities assigned by the management
Education:
*Bachelor degree and above in the biology, chemistry, pharmaceutical engineering, other related fields, or equivalent experience.
Experience:
*5 years working experience preferred.
*Relevant knowledge or experience in GMP production operations as well as medium preparation.
*Have excellent problem-solving skills, coordination and communication and management experience.
*Good abilities for planning and execution, analysis and decision making, be able to respond to emergency events.
*Good communication skills both in English and German desired.
*Must work a team member with a positive attitude and good learning ability.