Pharmaceutical Quality Manager
7 days ago
About PCI Pharma Services
We are a leading global contract development and manufacturing organization (CDMO) that provides a comprehensive range of services to support the development and commercialization of pharmaceutical products.
The Role
The Quality Assurance Officer will be responsible for ensuring that all quality-related tasks are completed within the required timescales and in compliance with regulatory requirements.
Main Responsibilities:
Develop and implement quality metrics to ensure site compliance and assist in the provision of data for Quality Management Reviews.
Perform periodic updates of the Self-Inspection Schedule to ensure it is up to date and compliant with regulatory requirements.
Manage and administer Customer Complaints, ensuring timely and effective resolution.
Track corrective and preventative actions from Internal and External audits, ensuring timely completion and closure.
Maintain and update the Approved Supplier List, ensuring compliance with regulatory requirements.
Perform vendor re-assessments to ensure continued compliance with regulatory requirements.
Coordinate external audits in accordance with the required schedule, ensuring timely and effective completion.
Ensure Quality Agreements and TSE Statements are periodically updated within the required timeframes.
Assist in the generation of Nitrosamines Statements, ensuring compliance with regulatory requirements.
Author quality-related documents, including Product Quality Reviews, ensuring accuracy and compliance with regulatory requirements.
Provide assistance during inspection readiness preparations, including completing SIPOC.
Requirements:
Experience of working within a pharmaceutical environment under GMP.
GMP Skill Level 1 is essential for this role.
Proficiency in IT, including Microsoft Office and quality management systems.
Previous experience within a Quality department is desirable, ideally within a cGMP/pharma environment.
Equivalent pharma industry experience.
Self-motivated and able to work independently.
Ability to get results through co-operation and influence.
Benefits:
Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you
Staff Engagement: We value your dedication with recognition schemes and long-service awards.
Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
On-Site Subsidized Canteen.
Cycle to Work Scheme.
Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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