Qualified Person - QP (Hybrid)


Our client, a reputable pharmaceutical company, is looking for a Qualified Person - QP. Your responsibilities would include: 

  • Ensuring that a quality management system is maintained
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to
  • Managing the day-to-day operations of the Quality department in liaison with the QA/RA Manager
  • Overseeing the Quality activities pertaining to the company's status as an MA holder
  • Upkeeping and maintaining of technical agreements
  • Liaising with Malta Medicines Authority as necessary in liaison with the QA/RA Manager
  • Reviewing the site master plan, site master file and policies
  • Preparing and managing of the annual internal audit schedule
  • Generating and reviewing the compilation of a periodical Product Quality Review
  • Generating and reviewing Standard Operating Procedures, Corporate Policy Statements, and other defined critical documentation
  • Representing the company during audits for clients, certifications, or whenever necessary
  • Performing Quality audits, both self-inspection and of distributors and third-party bulk and finished dosage form manufacturing sites
  • Generating and keeping updated training material
  • Providing and receiving training sessions on GMP/ GDP/ Quality topics are carried out for company personnel
  • Compiling and reviewing of all change requests, customer complaints investigations, and CAPA
  • Coordinating of return/s and recall/s with QA/RA Manager
  • Ensuring that suppliers and customers are approved
  • Compiling and reviewing of manufacturer’s change requests
  • Overviewing the Serialisation process and approve change controls

Skill-sets and Requirements

  • Possesses excellent written and spoken communication skills in relevant languages, including English
  • Multitasking and organisation skills
  • Analysing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution

Education & Experience

  • Qualified to act as Qualified Person (QP)
  • Tertiary degree level of education in a related field
  • Preferably a minimum of 2 years local experience within a similar role
  • Experience in managing and developing Quality Systems

Job Reference: GV870

  • Primary job focus
    Quality Control
  • Job type
    Full Time
  • Employment level
    Experienced (3 years +)
  • Employer industry
  • Languages
  • Job Reference
  • Closing Date
  • Date Published
  • Status

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