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We are seeking a Senior Microbiology QC Analyst to join our growing team within a GMP-compliant microbiology laboratory.

The role involves performing compendial microbiological testing and environmental monitoring activities to ensure the quality and compliance of finished pharmaceutical products, including microbial limit testing, water testing, environmental monitoring within GMP-classified cleanrooms, and microbial identification using the Vitek2 system.

The selected candidate will also support method suitability studies, equipment and cleanroom qualification activities, and assist with SOP updates, investigations, and deviation handling.

The ideal candidate should meet the following criteria:

• Degree or diploma in Microbiology, Biology, Biomedical Sciences, or a related scientific field.
• Minimum of 2 years of experience in a pharmaceutical QC Microbiology laboratory or similar.
• Knowledge of GMP requirements and microbiological testing techniques.
• Excellent attention to detail, well-organized, and proficient in time management.
• Excellent communication skills in English, both verbal and written.

What we offer:

• Competitive salary package with regular reviews and salary progression.
• Continuous professional development opportunities in a state of the art, brand-new laboratory equipped with the latest technologies.
• Comprehensive health insurance.

We are looking for a motivated and experienced Senior QC Analyst to join our growing team. In this role, you will work in a GMP-compliant chemistry laboratory, where your expertise will directly contribute to delivering high-quality finished products.

Key Responsibilities:

• Prepare, standardise and label stock solutions and laboratory reagents as required.
• Perform finished product and purified water testing using approved methods and specifications.
• Ensure proper handling, qualification, and calibration of laboratory equipment, including supporting external contractors and maintaining accurate records.
• Maintain and review QC documentation, SOPs, logs, and registers to ensure ongoing compliance.
• Support QC investigations, including deviations, OOX results, and change controls, and where required provide guidance to junior analysts.
• Carry out other Quality Control-related duties as required.

Job Requirements:

• Degree or diploma in a scientific field.
• Minimum of 3 years of experience in a pharmaceutical QC laboratory, with strong expertise in chromatographic techniques.
• Excellent attention to detail, well-organised, and able to prioritise tasks effectively.
• Excellent communication skills.
• Valid work permit.

What we offer:

• Competitive remuneration package with regular reviews and salary progression.
• Continuous professional development opportunities in a state-of-the-art, brand-new laboratory equipped with the latest technologies.
• Comprehensive health insurance.

We are seeking a Regulatory Affairs Specialist to support our regulatory activities and contribute to the success of our team.

This role is primarily focused on Regulatory Affairs, with additional exposure to Pharmacovigilance (PV) activities, offering a well-rounded opportunity across the product lifecycle.

As a Regulatory Affairs Specialist, you will play a crucial role in preparing, submitting, and managing regulatory documentation to ensure compliance with EU requirements. You will collaborate closely with cross-functional teams, including Pharmacovigilance, and maintain organized systems to drive efficiency and accuracy in regulatory and safety-related processes.

Key Responsibilities

• Regulatory Affairs (Primary Focus)
  • Preparation, review, and submission of variations to Marketing Authorisations (MAs), including safety-related variations, in line with EU and national requirements.
  • Oversee tracking and management of regulatory deadlines, ensuring proactive lifecycle management.
  • Manage company licence variations in coordination with internal stakeholders and regulatory authorities.
  • Contribute to and lead regulatory process design, optimisation, and documentation, including authoring and maintaining SOPs.
  • Act as a point of contact for cross-functional projects impacting regulatory compliance, including audits, inspections, and quality management reviews.
  • Maintain and improve internal tracking systems and regulatory processes.

• Pharmacovigilance (Supporting Role)
  • Support assessment and implementation of safety-related regulatory changes (e.g. SmPC/PIL updates, RMP updates).
  • Collaborate with PV teams to ensure alignment between regulatory submissions and safety data.
  • Assist in tracking and implementation of commitments arising from PSURs, RMPs, and safety variations.
  • Contribute to PV-related compliance activities.
  • Support maintenance of PV agreements and regulatory-PV interfaces.

Job Requirements:

• Degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 5 years’ experience in Regulatory Affairs within the pharmaceutical industry .
• Strong understanding of EU regulatory frameworks, including Variation Regulation, HMA/CMDh guidelines, and national requirements.
• Demonstrated experience in regulatory lifecycle management and safety variations.
• Exposure to Pharmacovigilance activities or willingness to develop PV knowledge.
• Ability to draft and implement procedures and internal workflows.
• Strong organisational and project management skills with attention to detail and a solutions-oriented mindset.
• Valid work permit.

What We Offer

• Competitive remuneration package
• Comprehensive health insurance
• Hybrid working arrangements
• Safe and conducive working environment
• On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies