The role of the Account Manager is to ensure that BAP Pharma Group (BAP Pharma Ltd and BAP US Inc) are compliant to both GMP and GDP requirements and follow the guidance stipulated by the local health authorities MHRA and FDA.  To also ensure that BAP Pharma Ltd are fully compliant with the UK Home Office Controlled Drugs regulations at all times. In addition, manage BAP Pharma to be fully compliant to the requirements of ISO9001:2015.

Responsibilities

  • Ensure compliance to GMP and GDP regulations
  • Support the maintenance of QMS – CAPAs, deviations, change controls and complaints
  • Support the RP with ensuring BAP Pharma adhere to the Falsified Medicines Directive
  • Support the Goods-in and Goods-out processes
  • Writing, reviewing and approving SOPs within the Electronic Quality Management System
  • Support the RP during Product recall, complaint investigation, deviation and CAPA implementations
  • Support the supplier and customer verification programme/development
  • Support the RP during Self-inspections and external audits
  • Oversee the warehouse operations and ensure that temperature conditions are maintained, and seasonal mapping and calibration activities are conducted in a timely manner
  • Provide support during client and MHRA inspections
  • Provide support during internal staff training on GxP elements
  • To ensure that the provisions of the WDA(H) and MIA(IMP) are met at all times
  • To ensure that BAP Pharma documentation are managed in accordance with Good Documentation Practices and Data Integrity
  • Support the RP during validation activities (Preparation of documentation & execution of testing)
  • To manage the Quality Key Performance Indicators
  • Support the RP during Quality Management Review Meetings

Position Requirements

  • Knowledge of The Human Medicines Regulation (SI2012/1916).
  • Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
  • Good Understanding of the GMP and GDP Regulations.
  • Good understanding of the WDA(H) and MIA(IMP) obligations.
  • Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use.
  • Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use (2013/C 343/01).
  • Educated to a degree level within a life science subject.

Competencies

  • Attention to Detail and Thoroughness
  • Concern for Standards
  • Excellent communication skills
  • Diplomacy with relevant stakeholders
  • Interpersonal awareness and sensitivity
  • Flexibility and Adaptability
  • Tenacity

Work Conditions

  • Reports directly to the Head of Quality / RP
  • From time to time overtime may be required to meet project deadlines
  • Ability to work under own initiative and as part of a team

If you would like to be considered for this position, please forward your CV to [email protected].