Qa Manager And Qp

Sandoz; Bracknell; On-site; GBP 75,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Job summary

Sandoz in Bracknell, United Kingdom, is seeking a Qualified Person (QP) to lead local quality activities and ensure GMP/GxP compliance across the quality systems. The role includes investigations, CAPAs, audits and continuous improvement with cross-functional collaboration.

The successful candidate will have 5+ years in pharma with GxP knowledge, strong problem solving and coaching abilities, and the capacity to work across IT-enabled quality platforms while coordinating with Global QA and MHRA.

Qualifications

• Eligibility as Qualified Person with experience of multiple dosage forms.
• 5+ years in the pharmaceutical industry with GxP knowledge.
• Knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Experience in process improvement and quality systems development.
• Strong communication and coaching abilities.

Responsibilities

• Lead local execution of quality systems and ensure compliance with GxP and SOPs.
• Monitor quality activities, run metrics, quality review and self-inspection.
• Perform risk/impact evaluations for product decisions and escalation situations.
• Maintain local SOPs, support audits and inspections as content expert.
• Investigate quality deviations, complaints, CAPAs and coordinate with third parties as needed.
• Develop IT platforms supporting quality systems and act in multiple roles.
• Ensure effective information flow between country organisation and Global QA.
• Lead quality initiatives, productivity and continuous improvement projects.
• Support batch release activities and QP declarations; review APQRs.
• Communicate with MHRA and maintain QP Code of Practice knowledge.
• Provide GxP education and training within the team.

Skills

GxP knowledge

Quality systems

Problem solving

Coaching/training

Interpersonal skills

Communication

Project management

Organisational skills

Job description

Job Description Summary

At Sandoz, our Purpose is pioneering access for patients

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. Provide leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation meeting internal and external stakeholder requirements. Streamline and improve quality processes, facilitate quality management and lead the development of a right first time, quality culture.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• 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

What you’ll bring to the role:

Essential Requirements:

• 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.

QA Manager and QP Bracknell, United Kingdom