Quality Assurance Specialist

Quality Assurance Specialist

Location: Marlow, Buckinghamshire (office-based) SL7 1TB

Salary: Up to £42,000 dependant on experience + bonus plan

Contract: Full time, Permanent

Benefits: Private Medical insurance, Life insurance, Company pension, Competitive leave, Flexitime, Free on-site parking, Company sick pay, Referral programme, Wellness programme

The Company

BAP Pharma is the fastest-growing, independently owned pharmaceutical clinical trials supply organisation, with specialist divisions in Comparator Sourcing, Secondary Packaging & Labelling/Global Storage & Distribution and Medicines Access.

Our story is one of incredible growth and success, which has culminated in receiving many prestigious awards, such as recognition in Diversity & Inclusion and Social & Environmental, and the continued expansion of our core business operations in the UK, Germany, and the USA.

We are now looking for qualified, experienced and passionate professionals who are dedicated to providing unparalleled customer service, to continue to drive our business forward and become a part of our success story.

The Role

The Quality Assurance Specialist is responsible for the development, implementation and maintenance of the Company’s quality management processes and improvement practices, as well as bringing these to life by providing internal trainings.

Work closely with the business management team and provide quality support with qualification and management of suppliers and customers, ensure compliance, support business growth and drive continuous improvement through technical expertise and great partnerships. Safeguard product users against potential hazards arising from poor distribution and manufacturer practices.

The successful candidate must have work experience with UK and EU legislation as outlined in the Job Requirements section.

Responsibilities

• Support the supplier and customer approval process to ensure new suppliers and customers are qualified and maintained in accordance with the internal procedures

• Perform licence verifications of the new and existing UK and non-UK suppliers and customers

• Provide support and advice to ensure Technical Agreements are in place and maintained between suppliers and customers and able to demonstrate experience in creating TA’s

• Utilise BAP’s electronic Quality Management System with regards to supplier and customer qualification processes and keeping it updated, ensuring an effective quality system is implemented and maintained for supplier and customer management

• Provide management and support of the complaints system and align with external parties to ensure the investigations are completed in timely manner

• Support the QP/RPi/RP during product recalls

• Train employees and ensure they understand the applicable SOPs

• Participate in client and regulatory authority inspections

• Perform and/or support internal self-inspections

• Support the Goods-In and Goods-Out processes and review documentation to ensure compliance to local SOPs and GDP requirements

• Perform Quality Control (QC) inspections/checks during start-up, in process and end of job for the secondary packaging and labelling activities and support the QP with release activities.

• Provide guidance and support on GDP and GMP compliance to ensure product quality is not compromised

• Provide Guidance and Support on Good Documentation Practice and Data Integrity to ensure GxP records are generated and retained appropriately

• Carry out risk assessments on business, GDP and GMP critical areas and has experience in conducting risk assessments

• Provide backup support in case of other quality members absence

• Conduct Quality tasks as requested by the line manager in support of business activities

Position Requirements

To be successful in this role you must have;

• Min 3 years’ experience in GMDP environment

• Experience of using electronic quality management system

• Excellent written and verbal communication skills

• Strong organisational skills with the ability to plan, prioritise and manage multiple tasks effectively

• Excellent attention to detail with proven ability to maintain a high level of accuracy

• Flexible and adaptable in approach, with a strong commitment to process excellence and compliance.

• Proactive and solution-focused approach

BAP Pharma is committed to enabling a supportive work environment, which is diverse and inclusive and based on mutual respect.

We offer comprehensive training and development programmes to employees to enable them to excel in their roles. We provide our team with a platform in which to continually progress and excel and deliver on our promises to our clients.

BAP Pharma – Promise delivered. Our people are results driven, tenacious and customer focused. If you think you have what it takes to be part of a successful team with an exciting future, please apply today!

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