CHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest standards through consistency, ambition and technical competency throughout the company.

This is a full-time opportunity based on-site for an experienced QA Specialist/Lead. Looking for a professional with a "can-do attitude" to provide SME support to our quality function. Reporting to the Quality Manager, you will bring the enthusiasm required to ensure the organisation's products meet all quality requirements. 

Job Summary:

The role involves leading a team responsible for all aspects of the quality function, ensuring compliance with relevant standards. You will be responsible for continual quality improvement, ensuring our products meet all requirements before reaching the client. Taking the lead across a range of Good Manufacturing and Distribution activities, delivering quality reports and products in line with documented methodologies, procedures, regulations and guidance. You will be a key point of contact for the management of Quality Assurance provision.

As the Quality Specialist/Lead you shall: 

• Provide Leadership, support and guidance in relation to all Quality  matters.
• Manage the site Qualtiy Management System and ensure lead/execution for progression of site-related deviations, change controls, associated risk assessments and CAPAs thereof.
• Ensure that the operations of the business and associated supply chain meet the relevant standards, including validation activities when required.
• Ensure products meet established quality standards and industry benchmarks.
• Handle complaints effectively
• Demonstrate effective relationship management between GMPM and external parties.
• Oversee all external and internal audits, including the management of competent authority inspections.
• Be responsible for site training
• Adhere to Health and Safety guidelines as well as legal requirements.
• Follow the company's core values, ensuring objectives are met.
• Any other duties that may reasonably be required.
• Client travel may be required as necessary and when applicable.

What You Need:

• A minimum of 5-10 years' experience in a Quality Assurance role within a pharmaceutical manufacturing environment preferably creams and liquids dosage forms.
• Knowledge of Human Medicines Regulations/Medical Device Regulations, Good Manufacturing Practice, Good Distribution Practice, ISO 9001, ISO 13485.
• Team Management within a quality environment
• Leadership Skills
• Management Skills
• Oversight of day-to-day Quality activities

Preferred but Not Essential:

• A degree-level qualification in a related subject preferably in pharmaceutical science.
• Understanding of medicinal drug products/medical device supply chains and associated external relationships.
• Experience of delivering training
• Project Management

Personal Characteristics:

• Excellent organisational skills
• Lead by example through the demonstration of the company's core values. 

If you feel you are the right person for this role, please don't hesitate to apply below with an up-to-date CV attached.

CHR Life Sciences are partnered with a Global Pharmaceutical company who are looking for a Contract QA Warehouse Manager.

Responsibilities include:

• Define Quality Warehouse Operations KPI’s, and schedules.

• Review and approve deviations and investigations arising from the process or related to the storage, and dispatch in the business unit and respond to customer queries related to product investigations.

• Host Customer inspections (audits), visits and support HA authority inspections as required.
• The Quality Manager is responsible for communicating the strategy to Quality leadership and working closely with all functional departments to ensure the Quality Warehouse Operational requirements are understood and ultimately adhered to.

The Successful candidate will:

• Have extensive experience in pharmaceutical quality departments.
• The successful candidate will have worked in a similar role previously and will demonstrate an understanding of GMP/GDP and regulatory compliance.
• Have a track record in managing teams and/or direct line management experience.

Job Title: Health, Safety, and Environment (HSE) Manager

Location: Germany

Company Overview: We are seeking an experienced Health, Safety, and Environment (HSE) Manager for a pharmaceutical construction project in Germany.

Key Responsibilities:

• Promote proactive health and safety culture.
• Maintain positive client relationships on H&S matters.
• Ensure compliance with national legislation.
• Integrate H&S policies, strategies and programmes.
• Monitor performance and report using indicators.
• Assist in incident investigations and root cause analysis.
• Coordinate safety training and workshops.

Qualifications:

• HSE management experience.
• Strong knowledge of H&S legislation and best practices.
• Excellent communication and leadership skills.
• Relevant certification preferred.
• Proficient in German.

Job Title: Health, Safety, and Environment (HSE) Manager

Location: Netherlands

Company Overview: We are seeking an experienced Health, Safety, and Environment (HSE) Manager for a pharmaceutical construction project in the Netherlands.

Key Responsibilities:

• Promote proactive health and safety culture.
• Maintain positive client relationships on H&S matters.
• Ensure compliance with national legislation.
• Integrate H&S policies, strategies and programmes.
• Monitor performance and report using indicators.
• Assist in incident investigations and root cause analysis.
• Coordinate safety training and workshops.

Qualifications:

• HSE management experience.
• Strong knowledge of H&S legislation and best practices.
• Excellent communication and leadership skills.
• Relevant certification preferred.
• Proficient in German.

CHR Life Sciences are pleased to be working in partnership with a UK based Pharmaceutical company, who are seeking a Head of Quality. 

Responsibilities include:

• To provide regulatory and GMP advice to the team, including deviations, quality incidents, change control, and audit findings.

• Create key relationships with influential customers and thought leaders in relation to product development and potential new opportunities.

• Post-holder will perform delegated responsibilities for Quality Assurance in conjunction with the Head of Quality Control and Head of Production as detailed in the EU Guide to GMP. The focus of the role will be as site lead for the compliance of GMP operations and processes.
• The post holder will have line management responsibility for other Senior quality professionals and wider QA team.

The Successful candidate will:

• Have extensive experience in pharmaceutical quality departments.
• Have previous experience working with MHRA / VMD, FDA and participating in regulatory agency inspections.
• The successful candidate will have worked in a similar role previously and will demonstrate an understanding of GMP and regulatory compliance.
• Have a track record in managing teams and/or direct line management experience. 

Senior Scientist

At CHR Life Sciences, we are excited to collaborate with a leading Biotechnology company based in the Bay area, currently in search of a senior scientist to join their analytical development team. As a senior scientist, you will play a pivotal role in executing characterization studies essential for establishing robust manufacturing control strategies. Your responsibilities will encompass drafting protocols and reports, as well as orchestrating the transfer of analytical methods to CROs/CMOs.

Key Responsibilities:

• Take the lead in developing, validating, and transferring analytical methods.
• Drive the development of analytical techniques and execute characterization studies to underpin raw material and formulation advancement.
• Provide expert oversight for drug substance release and stability testing.
• Assume authorship responsibilities for protocols, reports, and regulatory submissions as warranted.

The Ideal Candidate Will:

• Demonstrate proficiency in SEC-MALS methodology.
• Possess hands-on experience with state-of-the-art analytical apparatus (including HPLC, CE, SDS-PAGE, LCMS, and ELISA).
• Exhibit a track record of operating within regulated environments (GLP/GMP).
• Command knowledge of FDA, EU, and ICH regulatory frameworks.

Why Join: This presents a remarkable opportunity to become part of a rapidly evolving enterprise with ample prospects for career growth within the dynamic realm of biotechnology.

Key Technologies: SEC-MALS, Wyatt Technology, ASTRA software, HPLC, GMP, GLP, FDA, ELISA, Western Blot

CHR Life Sciences are pleased to be working in partnership with a UK based pharmaceutical business, who are seeking a Qualified Person.

Responsibilities include:

• In your role as a Qualified Person, you will drive the transformational quality culture initiatives across the site, define GxP practices and standards for the site, and lead gap assessments and improvement projects as required.
• You will provide quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools.
• As a QP you will escalate to the Head of Quality and SLT any trends and quality issues that are detected during batch review.
• You will provide leadership during agency inspections, perform QP batch certification and participate in internal and external audits.

The Successful candidate will:

• Be eligible to perform the duties of a Qualified Person under the provisions of Directive 2001/83/EC, Directive 2001/82/EC, Directive 2001/20/EC, and Statutory Instruments (SI) 2012 1916, SI 2004 1031 and SI 2013 2033.
• Have extensive experience in pharmaceutical quality departments.
• Possess in-depth knowledge of licensed products, processes, and legislation.
• Have previous experience working with MHRA / VMD, FDA and participating in regulatory agency inspections.

QP | Qualified Person | GxP | Quality | Internal Audits | External Audits | Audits | MHRA | Regulatory Affairs | Release | Batch | Quality Assurance

QA/QC Specialist

CHR Life Sciences are pleased to be working in partnership with a pharmaceutical company in the Southeast, who are seeking a QA/QC Specialist to join their growing team. As a QA/QC specialist, you will be responsible for drafting and maintaining COSH and radiation risk assessments, participating and leading root cause analysis and CAPA identification, and accurately perform quality control testing on all manufactured products at the LRP/HRP according to SmPC and EP guidelines.

Responsibilities include:

• In your role, you maintain and organize QC equipment calibration and maintenance schedules.
• You will assist the QA manager with the day-to-day activities.
• You will be responsible for validation activities, and preparation and execution of protocols.
• In your role you will, be responsible for reviewing compliance of production and analytical methods with GMP/specials guidelines.

The Successful candidate will:

• Have an understanding of ionising radiation local rules, COSSH and Health & Safety procedures.
• Have experience working within a GMP environment.
• Have previous experience with validation activities.
• Have experience working within QA/QC, preferably within a radiopharmacy environment.

Why apply:

Fantastic opportunity to join a rapidly developing business with the potential for career progression within the pharmaceutical industry.

Radiopharmaceuticals | GMP | COSSH| Quality Control | Quality Assurance

CHR Life Sciences are pleased to be working in partnership with a leading life sciences consultancy in Europe, who are seeking a Senior Regulatory Affairs Specialist.

Responsibilities include:

• Responsible for handling responses to regulatory agency questions.
• Act as an EU regulatory subject matter expert for your portfolio.
• Write, revise and review SOPs.
• Work closely with internal partners, ensuring company compliance.

The successful candidate will have:

• 4+ years regulatory affairs experience
• Relevant bachelor / masters degree
• Written and verbal English language skills.

This role will be based on site.