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- 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: Supportive team environment with exposure to regulatory operations.
- 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.
The predicted salary is between 40000 - 45000 £ per year.
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
- Quality Systems & Documentation
- 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
- Deviations, CAPAs & Risk Management
- 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
- Supplier & Customer Qualification
- 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
- Audits & Inspections
- 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
- Training & Continuous Improvement
- 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
- 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
- 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
- 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
Quality Assurance Officer in Watford employer: SKC Recruitment
Contact Detail:
SKC Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Officer in Watford
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you tailor your responses and show that you're genuinely interested in the role.
✨Tip Number 3
Practice common interview questions and scenarios related to Quality Assurance. Think about your past experiences and how they relate to the job description. Being ready will boost your confidence and help you shine during the interview.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the position. Plus, it keeps you on their radar as they make their decision.
We think you need these skills to ace Quality Assurance Officer in Watford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Officer role. Highlight your experience with GDP/GMP regulations and any relevant QA activities you've been involved in. We want to see how your skills match 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 and how your background makes you a perfect fit for our team. Don’t forget to mention specific experiences that relate to the job description.
Showcase Your Attention to Detail: As a QA Officer, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their work neatly and professionally, so double-check everything before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at SKC Recruitment
✨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 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 what the company is looking for.
✨Communicate Clearly
Since strong communication skills are essential for this role, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to get comfortable.
✨Ask Insightful Questions
Prepare some 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 it's the right fit for you.