QA Manager and QP

Sandoz UK & Ireland; Bracknell; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Job summary

Sandoz UK & Ireland is seeking a Qualified Person to ensure GMP compliance across local quality systems. You will lead audits, investigations and CAPA, maintaining SOPs and global standards while coordinating with Global QA.

The role requires extensive GxP knowledge and strong problem-solving abilities. You’ll play a key part in continuous improvement, risk assessments, and cross-functional collaboration within the country and with international teams.

Qualifications

• Life science degree level or equivalent experience.
• Eligibility as Qualified Person with experience of multiple dosage forms.
• >5 years experience in the pharmaceutical industry with GxP knowledge.
• Knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Knowledge of process improvement techniques.
• Good problem solving and evaluation techniques.
• Experience in developing quality systems and/or processes.
• Coaching/training/facilitation.
• Proficient with computer-based systems and applications.
• Strong interpersonal and collaboration skills with clear communication across levels.
• Operational excellence and continuous improvement mindset.
• Resilient, motivated, able to manage multiple priorities and plan workload.

Responsibilities

• Lead local execution of quality systems in line with GxP requirements and SOPs.
• Perform risk/impact evaluations related to product decisions and quality systems.
• Ensure local compliance with global standards and maintain SOPs; support audits and inspections.
• Investigate and resolve quality investigations, deviations, complaints and CAPAs.
• Develop knowledge of IT platforms supporting quality systems and act in multiple roles.
• Ensure effective communication of quality matters within the country and to Global QA.
• Lead quality improvement initiatives with project planning and milestones.

Skills

GxP knowledge

Quality systems

Regulatory knowledge

Problem solving

Audits & inspections

IT systems knowledge

Communication skills

Project management

Multitasking

Education

Life science degree

Job description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The Purpose Of The Role Is

To perform duties of the Qualified Person in compliance with all applicable GMP regulations and directives.

Your Key Responsibilities

• Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local workpractices, Responsibility for monitoring compliance of the quality activities/systems owned locally – including metrics, quality review and self-inspection. Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence.
• Perform routine risk/impact evaluations associated with product based decisions or the quality system and participate in escalation situations
• Ensure local compliance with global standards/SOP’s and maintain relevant local SOP’s. Communicate requirements and/or changes and act as content expert for audits and inspections using knowledge of associated systems
• Investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation (where necessary in conjunction with nominated third parties) to minimise impact on product availability and sales
• Gain expert knowledge of IT platforms/applications supporting quality systems and be able to act in multiple roles within that system as applicable
• Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Global QA organization and vice-versa including but not limited to issue escalation
• Develop and recommend changes for productivity and quality improvements. Lead in implementation of quality initiatives & continuous improvements including project planning, milestone delivery and communication within the team and cross functionally.
• Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management
• Work with the country organisation business brands to provide direction and support for all quality / GMP matters. Provide GxP education and training to others in the team and across the CO.
• Support and development of personnel in Sandoz Quality team using Capability Assessment and MyGrowth tools
• Resource planning with the team with responsibility to ensure personnel are trained to undertake GxP activities
• To conduct batch assessment and release activities, in a timely manner, and meeting relevant regulatory standards
• To lead activities supporting batch release, ensuring oversight of the Quality System and carrying out tasks such as QP declarations and review of APQR’s.
• Perform agreed communications with MHRA
• Maintain knowledge in accordance with the Qualified Person’s Code of Practice
• Support and development of personnel in Sandoz Quality team using Capability Assessment and MyGrowth tools
• Resource planning with the team with responsibility to ensure personnel are trained to undertake GxP activities
• Setting and review of objectives

Essential Requirements

What you’ll bring to the role:

• Life science degree level or equivalent experience
• Eligibility as Qualified Person iddeally with experience of multiple dosage forms
• >5 years Experience in the pharmaceutical industry, GxP knowledge
• Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Knowledge of process improvement techniques.
• Good working knowledge of problem solving and evaluation techniques.
• Development of quality systems and/or processes
• Coaching/training/facilitation
• Good level of skills in the use of computer based systems and applications
• Interpersonal relationships and collaboration. Good communication skills to ensure information is taken, used and given at all levels for maximum benefit to the business.
• Operational Excellence (includes problem solving & continuous improvement)
• Being Resilient, Motivated, Managing multiple priorities. Organisation of own and team workload – self-directed and able to flex to meet peaks in workload, project management

You’ll Receive

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz