Sterility Assurance Lead — Scale GMP Excellence

SallyQ AB

Uppsala kommun

On-site

SEK 1,100,000 - 1,550,000

Full time

14 days+

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Job summary

SallyQ AB is seeking a Sterility Assurance Lead to own and shape the site's sterility assurance strategy from day one. You will act as the SME for contamination control, aseptic processing and sterilization validation within a fast-scaling manufacturing environment.

Based at our Uppsala site, you will drive SAP/CCS programs, oversee environmental monitoring and sterilization validations, and lead CAPAs. You will be on site up to four days per week, collaborating with cross-functional teams to

Qualifications

Experience in sterile manufacturing environments.
Proven ability to lead investigations and CAPAs.
Strong documentation and data interpretation skills.
Familiarity with EU GMP Annex 1 and global regulatory expectations.

Responsibilities

Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS).
Oversee environmental monitoring, cleanroom qualification, and aseptic practices.
Review sterilization validations and lead media fill programs.
Drive contamination risk assessments, investigations, and CAPAs.
Act as SME during audits and inspections.
Provide training and mentorship in sterility assurance best practices.
Reside at the production site in Uppsala and be on site up to four days per week.