Quality Control Specialist, Environmental Monitoring, Galderma

SallyQ AB; Uppsala kommun; On-site; SEK 520,000 - 720,000; Full time

Job summary

Galderma is seeking a Quality Control Specialist - Environmental Monitoring to act as the technical authority for monitoring programs and cleanroom quality. You will ensure compliance with global regulatory requirements and serve as SME for environmental monitoring, contamination control, and cleanroom operations in sterile manufacturing.

You will lead monitoring programs, analyze data, design validations, and guide contamination control strategies.

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Infection Biology, Biochemistry, or a related field.
• At least 4-5 years of experience in microbiological laboratory work and/or production hygiene.
• Documented experience with ISO 13485 or GMP-regulated operations.
• Strong knowledge of environmental monitoring and contamination control in cleanroom environments.
• Professional proficiency in both Swedish and English, spoken and written.

Responsibilities

• Own and manage environmental monitoring programs for pharmaceutical and medical device manufacturing.
• Analyze and trend microbiological data from environmental monitoring of cleanrooms and clean media systems; identify excursions and drive investigations.
• Design and execute cleaning validations, establishing cleanliness standards and monitoring protocols aligned with GMP and regulatory expectations.
• Provide technical guidance on contamination control strategies, sampling strategies, and microbiological testing in aseptic manufacturing environments.
• Educate and qualify personnel for cleanroom work and aseptic practices in accordance with EU GMP Annex 1.
• Author, review, and update quality documentation including risk analyses (e.g. CCS, FMEA), validation reports, SOPs, and regulatory guidelines.
• Act as expert for quality matters including deviations, change controls, and risk assessments.
• Provide expert support during inspections and internal audits.
• Identify improvement opportunities and drive initiatives to strengthen microbiological control and cleanroom performance.

Skills

Environmental Monitoring

GMP Compliance

Cleanroom Operations

Data Trend Analysis

ISO 13485

Regulatory Documentation

Quality Investigation

Education

Bachelor's or Master's in Microbiology / related

Job description

The Role

Galderma is looking for a Quality Control Specialist - Environmental Monitoring who will act as the technical authority for environmental monitoring programs and cleanroom quality. This role ensures compliance with global regulatory requirements and serves as the SME for environmental monitoring, contamination control, and cleanroom operations in sterile manufacturing.

Key Responsibilities

• Own and manage environmental monitoring programs for pharmaceutical and medical device manufacturing.
• Analyze and trend microbiological data from environmental monitoring of cleanrooms and clean media systems; identify excursions and drive investigations.
• Design and execute cleaning validations, establishing cleanliness standards and monitoring protocols aligned with GMP and regulatory expectations.
• Provide technical guidance on contamination control strategies, sampling strategies, and microbiological testing in aseptic manufacturing environments.
• Educate and qualify personnel for cleanroom work and aseptic practices in accordance with EU GMP Annex 1.
• Author, review, and update quality documentation including risk analyses (e.g. CCS, FMEA), validation reports, SOPs, and regulatory guidelines.
• Act as expert for quality matters including deviations, change controls, and risk assessments.
• Provide expert support during inspections and internal audits.
• Identify improvement opportunities and drive initiatives to strengthen microbiological control and cleanroom performance.

Your Profile

You are an experienced microbiologist with a strong quality mindset and a passion for regulatory compliance and GMP excellence. You combine deep technical knowledge of environmental monitoring and cleanroom operations with the ability to communicate complex concepts clearly to both technical and non-technical stakeholders. You’re detail-oriented and methodical, bringing structure and rigor to data analysis, trend identification, and investigations.

You work independently with strong self-direction, yet you’re an excellent team player who thrives collaborating across functions. You’re solution-oriented, comfortable working in a regulated environment, and driven to identify and implement improvements that strengthen contamination control and operational excellence. You see this role as an opportunity to shape quality standards and establish best practices within a fast-scaling dermatology organization.

Requirements

• Bachelor’s or Master’s degree in Microbiology, Infection Biology, Biochemistry, or a related field.
• At least 4-5 years of experience in microbiological laboratory work and/or production hygiene.
• Documented experience with ISO 13485 or GMP-regulated operations.
• Strong knowledge of environmental monitoring and contamination control in cleanroom environments.
• Professional proficiency in both Swedish and English, spoken and written.

Skills

• Advanced expertise in environmental monitoring programs, sampling strategies, and microbiological testing methods in aseptic manufacturing.
• Strong knowledge of cleanroom classification, qualification, and monitoring in line with EU GMP Annex 1.
• Experience with cleaning validation, disinfection principles, and clean media systems.
• Proven ability to analyze and trend microbiological data, identify patterns, and investigate excursions.
• Experience with deviation management, risk assessments (FMEA, CCS), and quality investigations.
• Excellent documentation and technical writing skills for validation reports, SOPs, and quality documentation.
• Strong communication and collaboration skills with the ability to influence cross-functional teams and build trust.
• Structured, solution-oriented approach to problem-solving and continuous improvement in a regulated environment.

About Galderma

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin shapes our lives, we are advancing dermatology for every skin story.

We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.