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- Tasks: Ensure compliance with UK/EU regulations and maintain quality systems in a pharmaceutical setting.
- Company: Join Vivanta Generics, a fast-growing generic pharmaceutical company in the EU.
- Benefits: Enjoy a full-time role with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team that values quality and compliance in healthcare.
- Qualifications: Requires a degree in Pharmacy and 4-6 years of QA or compliance experience.
- Other info: Ideal for detail-oriented individuals passionate about improving pharmaceutical standards.
The predicted salary is between 36000 - 60000 £ per year.
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Job title: Quality Compliance Officer
Location: London, United Kingdom
Experience: 4 to 7 years in Pharmaceutical Quality Assurance
Type: Full-time, Permanent
Department: Quality Assurance
________________________________________________________________________________
About Vivanta Generics / MSN Labs
Vivanta Generics is one of the fastest growing generic pharmaceutical company in the European Union (EU), with focus on core markets in the EU. It’s a fully owned subsidiary of MSN Labs, India. Owing to its’ vast portfolio of products to offer, along with high quality standards and fully backward integrated manufacturing, Vivanta stands out as a reliable, fast-growing generic pharmaceutical company.
Purpose of the Role:
To ensure that MSN UK/EU and Vivanta Generics operations within the pharmaceutical company comply with UK and EU Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and other applicable regulatory requirements. The Quality Compliance Officer supports the maintenance and continuous improvement of the pharmaceutical Quality System (PQS), ensuring inspection readiness and alignment with MHRA and EMA expectations for MSN UK/EU and Vivanta Generics.
Key Responsibilities:
1. Regulatory Compliance
- Monitor, interpret, and communicate updates in UK/EU pharmaceutical legislation, guidance, and
- GMP/GDP requirements.
- Ensure site compliance with MHRA and EMA regulations and maintain readiness for inspections.
- Support implementation of corrective and preventive actions (CAPAs) following audits and regulatory inspections.
2. Quality Systems
- Support the development, maintenance, and continuous improvement of the Pharmaceutical Quality System (PQS).
- Maintain and review controlled documents including SOPs, policies, and technical agreements.
- Manage the deviation and change control systems to ensure timely investigation, risk assessment, and implementation.
3. Audits and Inspections
- Participate in and support internal audits and external supplier audits.
- Ensure timely closure of audit observations and monitor CAPA effectiveness.
- Prepare and assist during regulatory inspections (e.g. MHRA, EMA).
4. Training and Compliance Culture
- Deliver GMP/GDP training sessions to ensure personnel are competent and up to date with current
- requirements.
- Promote a strong quality culture and compliance mindset across all departments.
5. Documentation and Record Management
- Review and approve GMP records including batch manufacturing records, cleaning records, and environmental monitoring data.
- Ensure document control processes align with Annex 11 (Computerized Systems) and EU GMP.
- Support risk assessments in accordance with ICH Q9 and EU GMP guidelines.
- Participate in quality reviews and trend analyses.
Qualifications and Experience:
- Masters or Bachelor’s degree in Pharmacy.
- Sound knowledge of EU and UK GMP/GDP regulations.
- Minimum 4–6 years and experience in pharmaceutical QA or compliance roles.
- Experience with MHRA inspections or EU QMS frameworks, working experience in the MIA site.
- Familiarity with Annex 16 (Certification by a QP), Annex 11, and ICH guidelines.
- Experience with Sterile Dosage forms.
Skills and Competencies:
- Strong attention to detail and analytical skills.
- Proficiency in managing documentation and quality systems.
- Ability to work cross-functionally and meet tight deadlines.
- Professional integrity and ability to handle confidential information.
- Excellent in computer system and eQMS
Seniority level
-
Seniority level
Associate
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Pharmaceutical Manufacturing
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Quality Compliance Manager employer: MSN LABORATORIES EUROPE LIMITED
Contact Detail:
MSN LABORATORIES EUROPE LIMITED Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Compliance Manager
✨Tip Number 1
Familiarise yourself with the latest UK and EU GMP/GDP regulations. Being well-versed in these guidelines will not only help you during interviews but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience with MHRA inspections. Engaging with them can provide valuable insights and potentially lead to referrals that could boost your chances of landing the job.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios related to CAPAs and audit processes. Being able to discuss your past experiences and how you've handled similar situations will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work cross-functionally by preparing examples of how you've collaborated with different departments in previous roles. This skill is crucial for a Quality Compliance Manager, and demonstrating it can make a strong impression.
We think you need these skills to ace Quality Compliance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmaceutical quality assurance, particularly focusing on compliance with UK and EU regulations. Use specific examples that demonstrate your knowledge of GMP and GDP.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality compliance in the pharmaceutical industry. Mention your experience with MHRA inspections and how you can contribute to maintaining high standards at Vivanta Generics.
Highlight Relevant Skills: Emphasise skills such as attention to detail, analytical abilities, and experience with documentation management. These are crucial for the Quality Compliance Manager role and should be clearly stated in your application.
Showcase Continuous Improvement Initiatives: If you have led or participated in initiatives aimed at improving quality systems or compliance culture, make sure to include these in your application. This demonstrates your proactive approach and commitment to quality.
How to prepare for a job interview at MSN LABORATORIES EUROPE LIMITED
✨Know Your Regulations
Familiarise yourself with UK and EU GMP/GDP regulations before the interview. Being able to discuss specific guidelines and how they apply to the role will demonstrate your expertise and commitment to compliance.
✨Showcase Your Experience
Prepare to discuss your previous experience in pharmaceutical quality assurance roles, particularly any involvement with MHRA inspections or CAPA processes. Use specific examples to illustrate your contributions and successes.
✨Emphasise Attention to Detail
Quality Compliance Managers need a keen eye for detail. Be ready to provide examples of how your attention to detail has positively impacted your previous work, especially in documentation and quality systems management.
✨Promote a Quality Culture
Discuss how you have previously fostered a culture of quality and compliance within teams. Highlight any training sessions you've conducted or initiatives you've led to improve understanding of GMP/GDP among staff.