Global Quality Specialist - Regulatory & GMP Compliance

Jobtailor; Uppsala kommun; On-site; SEK 600,000 - 800,000; Full time

Job summary

Jobtailor is seeking a Quality Assurance professional to contribute to robust QA systems and oversee regulatory compliance in a regulated manufacturing environment.

You will manage batch records, SOPs, risk assessments, and validation protocols, ensuring alignment with cGMP and ISO standards while identifying process improvements.

Qualifications

• Bachelor’s degree in a regulated field is required.
• 2–5 years of QA experience in medical device, pharmaceutical, or regulated industry.
• English language fluency required; other languages are advantageous.
• Strong knowledge of manufacturing processes for sterile products and related QA controls.
• Proficiency in documentation management and record-keeping.
• Familiarity with cGMP, FDA, ISO 13485, MDR, and international guidelines.

Responsibilities

• Contribute to the development, implementation, and maintenance of quality systems including complaint, deviation, change control, CAPA, and risk management.
• Execute product release activities in compliance with regulatory requirements.
• Provide QA oversight for sterile manufacturing operations including aseptic processing and environmental monitoring.
• Manage and review quality documentation such as batch records, SOPs, risk assessments, and validation reports.
• Stay updated with regulatory requirements and industry best practices in QA.
• Identify opportunities for process improvement and quality enhancement.

Skills

Quality Assurance

Regulatory compliance

Documentation management

Communication skills

Independent and collaborative work

English fluency

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Job description

• Contribute to the development, implementation, and maintenance of robust quality systems, including complaint management, deviation management, change control, CAPA, and risk management processes.
• Execute product release activities in compliance with regulatory requirements and company standards.
• Provide QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring.
• Manage and review quality documentation, including batch records, standard operating procedures (SOPs), risk assessments, validation protocols, and reports.
• Stay up to date with regulatory requirements and industry best practices related to quality assurance.
• Identify opportunities for process improvement and quality enhancement.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
• 2–5 years of experience in a Quality Assurance role within the medical device, pharmaceutical, or other regulated industry.
• Fluency in written and spoken English; additional languages are considered an advantage.
• Strong operational knowledge of medical device or pharmaceutical manufacturing processes, including the production of sterile biological drugs, terminally sterilized products, and/or aseptically filled products.
• Proficiency in documentation management.
• Familiarity with regulatory requirements, including cGMP, FDA regulations, ISO 13485, MDR, and international guidelines.
• Excellent communication skills.
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.

Core Competencies

Demonstrates expertise in Quality Assurance processes, including complaint management, deviation management, and regulatory compliance in the pharmaceutical and medical device industries. Proficient in documentation management and maintaining quality systems to ensure adherence to cGMP and FDA regulations.

Highest-signal resume keywords

• Quality Assurance Experience
• Regulatory Compliance Knowledge
• Documentation Management Proficiency
• Aseptic Processing Oversight
• Process Improvement Identification

ATS Optimization Keywords

Hard Skills

• Quality Systems Development
• Complaint Management
• Deviation Management
• Change Control
• CAPA
• Risk Management
• Batch Record Review
• Standard Operating Procedures (SOPs)
• Validation Protocols
• Environmental Monitoring

Soft Skills

• Excellent Communication Skills
• Ability to Work Independently
• Collaborative Teamwork

Industry Keywords

• CGMP
• FDA Regulations
• ISO 13485
• MDR
• Sterile Manufacturing
• Pharmaceutical Manufacturing
• Medical Device Industry
• Regulated Industry
• Quality Documentation
• Process Improvement