At a Glance
- Tasks: Ensure quality compliance and improve the Quality Management System in a fast-paced pharmaceutical environment.
- Company: Join a growing pharmaceutical organisation with a collaborative culture.
- Benefits: Competitive salary, ongoing training, and career progression opportunities.
- Other info: Dynamic role with exposure to regulatory audits and continuous improvement initiatives.
- Why this job: Make a real impact on quality assurance and regulatory compliance in healthcare.
- Qualifications: Degree in Life Sciences and experience in pharmaceutical QA required.
Location: Watford
Salary: £40,000-£45,000
Reporting To: Head of QA / Responsible Person
Job Overview
We are seeking an experienced and proactive Senior Quality Assurance Officer to support the Head of QA and Responsible Persons with all Quality and Regulatory activities across the business. The successful candidate will play a key role in maintaining and continuously improving the Quality Management System (QMS), ensuring compliance with GDP/GMP requirements, and supporting regulatory obligations in line with MHRA, Home Office, and EU regulations. This role requires a strong understanding of pharmaceutical quality systems, supplier oversight, deviations, CAPAs, audits, and GDP operations. The Senior QA Officer will work closely with operational departments to ensure all activities relating to the procurement, storage, distribution, export, and handling of pharmaceutical products are conducted in accordance with regulatory requirements and company procedures. The ideal candidate will possess excellent communication skills, strong attention to detail, and the ability to manage multiple quality activities within a fast-paced pharmaceutical environment.
Key Responsibilities
- Quality & GDP Compliance
- Support the Responsible Person in maintaining GDP compliance and WDA obligations
- Ensure continuous monitoring and improvement of the Quality Management System (QMS)
- Ensure compliance with MHRA, Home Office, GDP, GMP, and EU regulatory requirements
- Provide QA support across all departments to ensure regulatory compliance is maintained
- Support recall management, incident handling, and escalation processes
- Prepare, review, update, issue, and control SOPs and quality documentation
- Review SOPs related to GDP/GMP activities and provide support to the Head of QA/RPs
- Maintain quality department logs, trackers, and controlled documentation systems
- Ensure effective filing and archiving of all quality-related records, both electronically and hard copy
- Act as scribe during Quality Review meetings and support quality reporting activities
- Manage and investigate deviations, CAPAs, complaints, and temperature excursions within agreed timelines via eQMS
- Initiate and support change control activities and associated risk assessments
- Conduct risk assessments in line with ICH Q9 principles
- Identify potential impacts of proposed changes and support implementation activities
- Manage supplier and customer qualification activities, including due diligence and QTA review
- Verify UK, EEA, and non-EU pharmaceutical suppliers and customers
- Conduct licence verification and compliance checks on suppliers and customers
- Draft, review, and maintain Quality Technical Agreements with subcontractors and third parties
- Support MHRA inspections and regulatory audits
- Conduct internal and external audits of vendors and suppliers
- Provide QA oversight of warehouse operations including goods-in, quarantine, storage, distribution, and destruction activities
- Support GDP training activities and maintain training records
- Develop GDP training tools and materials where required
- Monitor staff training compliance across departments
- Support continuous improvement initiatives within the Quality function
- Monitor and report quality KPIs and support management review processes
- Attend training sessions and meetings as required by management
Qualifications & Experience
- Degree in Life Sciences or related scientific discipline
- Strong understanding of GDP/GMP regulations, ICH guidelines, ISO 9001, and EU pharmaceutical regulations
- Experience working within a pharmaceutical QA environment
- Knowledge of pharmaceutical storage and distribution requirements under GDP
- Exposure to MHRA inspections and regulatory audits
- Experience managing deviations, CAPAs, change controls, supplier qualification, and quality documentation
- Experience within pharmaceutical wholesale, distribution, manufacturing, or import/export operations preferred
Skills & Competencies
- Strong written and verbal communication skills
- Excellent attention to detail and organisational skills
- Ability to multitask and prioritise workload effectively
- Strong decision-making and problem-solving abilities
- Confident working independently and collaboratively within cross-functional teams
- Proficient in Microsoft Office including Word, Excel, and Outlook
- Professional, proactive, and quality-focused approach
What is on offer
- Opportunity to work within a growing pharmaceutical organisation
- Exposure to regulatory, GDP, and quality operations
- Collaborative and supportive working environment
- Ongoing professional development and training opportunities
- Career progression within Quality and Regulatory Affairs
Senior QA Officer in Watford employer: SKC Recruitment Ltd
Contact Detail:
SKC Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Officer in Watford
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QA. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GDP/GMP regulations and quality systems. We recommend creating a cheat sheet with key points to discuss, so you can impress the interviewers with your expertise.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of specific examples where you've managed deviations or CAPAs effectively. This will demonstrate your hands-on experience and ability to handle challenges in a fast-paced environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Senior QA Officer in Watford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior QA Officer role. Highlight your experience with GDP/GMP regulations and any relevant quality systems you've worked with. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the pharmaceutical industry. Share specific examples of how you've contributed to quality improvements in past roles, and let us know why you want to join StudySmarter.
Show Off Your Communication Skills: Since this role requires excellent communication skills, make sure your application reflects that. Use clear and concise language, and don't forget to proofread for any typos or errors. We appreciate attention to detail!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at SKC Recruitment Ltd
✨Know Your Regulations
Make sure you brush up on GDP, GMP, and EU regulations before the interview. Being able to discuss these in detail will show that you understand the core of the Senior QA Officer role and can hit the ground running.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've managed deviations, CAPAs, or conducted audits. This will help demonstrate your hands-on experience and how it aligns with the responsibilities outlined in the job description.
✨Communicate Clearly
Since excellent communication skills are a must for this position, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to get comfortable discussing your qualifications.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's Quality Management System and their approach to continuous improvement. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.