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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
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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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