Mgr Quality Control

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
People Leader

All Job Posting Locations:
Uppsala, Uppsala County, Sweden

Job Description:

JOB POSITION SUMMARY

Quality assurance of chemical and microbiological testing and controls performed on products, raw materials/input materials, media, and manufacturing processes (including environmental hygiene), as well as quality assurance of validation and maintenance activities within the chemical and microbiological laboratory.

Process Owner for the UQC/UQM laboratory process.

Equipment Owner for laboratory systems within UQC/UQM.

Review and approve documentation, test methods, and processes for the Quality Control laboratory.

Review and approve laboratory investigations and non-conformity investigations.

Replace Head of UQ during short-term absences, in accordance with a specific delegation of authority.

DUTIES & RESPONSIBILITIES

Lead and develop the laboratory to ensure that AMO Uppsala AB and UQ achieve their objectives regarding quality & compliance, delivery reliability, and cost efficiency.

Plan and allocate resources and budget for QC Chemistry, Incoming Goods Inspection, and Microbiology.

Responsible for cost centers 1213203550 and 1213203650 in accordance with the company's current approval authority policy.

Line management responsibility for QC Chemistry, Incoming Goods Inspection, and Microbiology, as delegated.

Member of the Quality Leadership Team.

Ensure that all required chemical, physical, and microbiological tests and controls are performed on products, raw materials/input materials, media, and manufacturing processes in accordance with pharmacopoeial requirements and other applicable regulations.

Ensure that processes are validated and qualified within the chemical and microbiological laboratories, as well as maintenance and calibration activities are in compliance with applicable requirements.

Review and approve documents related to chemical, physical, and microbiological testing, test methods, and annual summaries/reports.

Review and approve assessments and rationales related to chemical and microbiological testing an...