Quality Officer

5 months ago

Hemel Hempstead, United Kingdom Firstline Pharma Ltd Full time

**Company Overview**:
Ravalco Group of companies include Firstline Pharma Ltd (FLP), Vantage Pharmaceuticals Ltd (VPL) and Nash Chemists.

FLP is a growing pharmaceutical wholesaler, including the import and export of a wide range of healthcare products, domestically and globally, and is also building its own portfolio of MAs.

VPL is a pharmaceutical company with its own WDA and MAs, has some MAs, is exclusive UK distributor for others, and has its own products in R&D.

With the rapid growth of our group of companies we are looking for a group wide Quality Officer to join our expanding team. We are looking for an ambitious individual who can drive quality and compliance through the business, ensuring the highest industry standards.

In this role you will be a key member of the team, working closely with the other Quality team members and supporting the sales and warehouse teams to ensure that the company always maintains the highest possible standards. Key to your success will be your ability to work strategically, develop a robust Quality Management Systems, implement quality initiatives, and have a in depth knowledge of the MHRA and GDP.

**Role Overview**

As a Quality Officer, you will play a vital role in ensuring that our company maintains the highest standards of quality, compliance, and customer satisfaction.

You will be responsible for various aspects of quality management, including customer and supplier approvals, training coordination, SOP management, self inspections, deviations and CAPAs, documentation audits, and more. Your contribution will be critical in upholding our Good Distribution Practice (GDP) standards, fostering a culture of quality throughout the organization, and ensuring compliance with regulatory requirements.

**Key Responsibilities**
- **Customer and Supplier Approvals **_
- Carry out thorough checks on new suppliers and customers to ensure we only supply companies licensed to handle those products
- Carry out thorough periodic checks on existing suppliers and customers to ensure we only supply companies licensed to handle those products
- Regularly review and maintain records of supplier and customer approvals in the ERP system
- **Training Coordination**_
- Assist in organizing and notifying personnel of required training sessions, including both new employee orientation and refresher training.
- Ensure that initial and continuous training programs for GDP are implemented and maintained
- Complete the administration and filing of all training records
- Maintain accurate training records and update the training matrix to track completed and outstanding training requirements
- Provide monthly reports on the status of the training matrix
- **SOP Management**_
- Support the administration and filing of standard operating procedures (SOPs) (paper and electronic back-ups)
- Keep SOP indices up to date
- Be responsible for notifying the SOP authors and owners of periodical SOP reviews that are approaching
- Provide monthly reports on overdue SOP reviews
- **Internal Audits **_
- Support and monitor the Internal audit process to ensure it is carried out as per the established plan
- Report monthly on progress and compliance against the internal audit plan
- **Deviations and Corrective and Preventive Actions (CAPAs)**_
- Support the administration of non-compliance reporting as required
- Carry out administration regarding progression, completion and filing of deviations and CAPAs
- Provide regular updates on the status of deviations and CAPAs, including managing completion dates and extensions as necessary
- **Documentation and Audits**_
- Support the collation and filing of purchase orders and sales orders
- Conduct audits of transactional documentation to ensure completeness and accuracy
- **Quality Culture and Compliance**_
- Collaborate with operational and quality teams to address returned, rejected, recalled, or falsified products
- Contribute to updating and maintaining the Quality Management Systems (QMS) on site
- Foster a company-wide culture of GDP compliance and overall quality excellence through development, mentoring, and training initiatives
- Ensure effective handling of customer complaints and contribute to continuous quality improvements
- **Regulatory Compliance and Safety**_
- Stay informed about legal and regulatory requirements relevant to our industry
- Support company-wide GDP compliance and inspections, adhering to all safety standards and SOPs
- Support the co-ordination of any recall operations for medicinal products

**Required Experience and Skills**
- Experience (3-5 years) working in a Regulatory Compliance /Quality Assurance role within pharmaceutical wholesale environment/GDP
- Bachelor’s degree (BSc) in a Science related degree
- Strong understanding of quality management principles and regulatory requirements
- Strong oral and written communication with the ability to work professionally
- Ability to build good working relationships, and use p

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