Senior Quality Assurance Officer

at  Firstline Pharma Ltd

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 and has a Manufacturer’s ‘Specials’ License for importation from a Third Country.
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.

REQUIRED EXPERIENCE AND SKILLS

• Experience (3-5 years) working in a Regulatory Compliance /Quality Assurance role within pharmaceutical wholesale environment - GDP and/or Manufacturing G environment -GMP
• 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 persuasion and negotiation skills to influence positive outcomes
• Take ownership and accountability
• Detail orientated with a meticulous approach to work – in particular record keeping
• A proactive, flexible, and motivated attitude to work and work collaboratively with the team
• Demonstrable experience working decisively in a fast-paced environment
• Proven time management and prioritisation skills
• Strong IT stills Microsoft Office (including Excel) and the ability to quickly learn other company systems
• Keeps up to date with all regulatory changes
• Adaptable to an ever-changing work environment

ROLE OVERVIEW

As a Senior 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) and Good Manufacturing Practice (GMP) standards, fostering a culture of quality throughout the organization, and ensuring compliance with regulatory requirements.

KEY RESPONSIBILITIES

Customer and Supplier onboarding and 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 and GMP 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 and GMP compliance and inspections, adhering to all safety standards and SOPs
• Support the co-ordination of any recall operations for medicinal products