Title GDP Quality Manager-Pharmaceutical Quality, Technical & Compliance
Salary £40,000 – £50,000 PA
Location Dartford
Job Information

Quality Manager – Pharmaceutical Quality, Technical & Compliance

Full-time, Permanent

My client is a leading pharmaceutical wholesaler serving the pharmaceutical and healthcare industries in the UK and throughout the world. An exciting opportunity has risen for a GDP Quality Manager. Reporting to the Responsible Person (RP) & Directors you will be responsible for assisting the RP with managing the quality management system according to operational procedures and requirements of GDP regulations.

This is a hands on role focused on making things happen.
You will have passion for your work and be relentlessly focused on achieving best practice.
As well as becoming the go-to person for quality advice, you will set the tone for a proactive, positive quality-focused culture working within our values and behaviours.
Your role will be proactive, not reactive, driving team understanding and ensuring we get things right first time, every time.
You will be experienced in effecting change internally and externally through a collaborative management style.
With proven ability to juggle multiple priorities, unstinting attention to detail and high quality delivery, you will work with a range of internal and external stakeholders to get things done.
You will be an inspirational but practical team player and influencer with strong operational capabilities, excellent team working skills and the ability to quickly form strong working relationships.
Key Responsibilities:

The role involves working closely with and reporting to the Responsible Person to ensure all the activities of the organisation are compliant with the relevant legal and regulatory frameworks this includes, but is not limited to:

Assist the RP in ensuring that the provisions of the WDA(H) are met at all times
Actively assist in the implementation and maintenance of quality systems such as deviation / CAPA management, change controls and risk assessments; and ensure that quality systems are continuously improved with the objective of assuring GDP compliance
Identify, write, gain approval and implement critical GDP documents and assist in training as required on new/ revised procedures
Support the RP with ensuring adherence to the Falsified Medicines Directive (FMD)
Support the RP during product recalls and complaint investigations
Manage the supplier and customer verification process
Support the RP during Self-inspections, external audits and during client and MHRA inspections
Oversee the warehouse operations (goods in & out) and ensure that temperature conditions are maintained, and seasonal mapping and calibration activities are conducted in a timely manner.
Ensure that documentation is managed in accordance with good documentation practices and data integrity
Day to Day responsibilities

Most of the day to day transactions will be carried through our ERP/QMS system which when uploaded with the correct information, the system can control not only what products can be sold and purchased, but also whom they can be sold to and purchase from.

The products will be loaded by the sales and admin team and will be audited by the QM. All of the customers and suppliers can only be loaded by the QM or Commercial Manager (with addition verification))

This will form part of the QM’s daily duties.

Maintain and improve the current ERP/QMS in accordance with company and GDP guidelines

Maintain and update ERP system with the latest MHRA, European and Department of health alerts and manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP
Oversee the loading and audit of new and existing products that the loaded onto the ERP system so that they can demonstrate compliance with GDP
Re-verification of suppliers and customers on the ERP system
carry out due diligence checks and ensure that suppliers and customers are qualified
Oversee the loading and audit of new and existing products that the loaded onto the ERP system so that they can demonstrate compliance with GDP
ensure all necessary checks are carried out and that medicinal products are authorised for sale
Skills and Experience:

Good understanding of the GDP Regulations and WDA(H) obligations.
Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use
Significant and demonstrable experience of working in a similar quality assurance/compliance related role within the Pharmaceutical Industry.
Excellent working knowledge of ISO 13485, MDD and MDR 2017/745.
Excellent oral and written communication skills and ability to present at different levels of the organisation.
Strong interpersonal skills with the ability to work cross functionally across the business, with suppliers and customers.
Excellent attention to detail and the ability to work to tight and challenging targets and deadlines.
Have the ability to stick to stringent time lines and enforce
Benefits:

On-site parking
Schedule:

8 hour shift
COVID-19 considerations: Masks provided on site and hand sanitiser available around the premises

Experience:

Pharmaceutical Quality Management: 2 years (Required)
If interested please contact Tom at Premier Recruitment(S.E)

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