7 Jun '21
Quality Assurance Pharmacist - OTC Division

Medical, Gauteng JHB - Eastern Suburbs

Market - Related

A leading pharmaceutical company is seeking a Quality Assurance Pharmacist within their OTC Division to work with the QA Manager to establish, implement and maintain the Quality Management System (QMS), including systems such as complaint handling, recall handling, deviation management, root cause analysis, CAPA management, change control, and quality risk management.

  • Assist Plant QA with the Quality Assurance Function of the Sterile Facility
  • Create and review written procedures and other documents, including amendments
  • Ensure adequate monitoring and control of the manufacturing environment
  • Ensure plant hygiene is to the required standard
  • Ensure that adequate QA training, including application and principles of QA is rolled out and maintained
  • Assist with line opening and closures when needed
  • Oversee the performance and evaluation of in-process controls
  • Ensure adequate retention of records
  • Monitor compliance with GMP requirements in the sterile plant
  • Ensure inspection, investigation and taking of samples in order to monitor factors that may affect product quality
  • Evaluate batch records
  • Approve and monitor activities carried out under (third party) contract
  • Check the execution of maintenance of the plant, premises and equipment
  • Ensure that the appropriate validations, including those of analytical procedures and calibrations of control equipment are carried out
  • Ensure that the required initial and continuing training of plant personnel is carried out and adapted according to need
  • Participate in external vendor audits
  • Participate in validation programs, including media fill
  • Ensure that information for product quality reviews are collated timeously
  • Assist with quality management reviews from the sterile plant perspective
  • Assist with developing and monitoring of departmental budgets, including capex and expense spending
  • Develop, manage and report departmental and plant quality objectives and indicators
  • Assist with regulatory audits and response documents
  • Work with the QA Managers of other group's units to ensure shared disciplines are maintained

Requirements:

  • Bachelor Pharmacy Degree
  • Registration with South African Pharmacy Council
  • 5 years’ QA experience within a pharmaceutical manufacturing environment
  • Sterile experience is required
  • cGMP skills
  • Computer Literacy – MS Office (proficient in Excel, Word and Power Point
  • Self-Discipline, conscientious
  • Integrity, honesty and responsibility
  • Ability to work in solitude
  • Cleanliness
  • No chronic skin, hair or respiratory conditions
  • Does not fidget
  • Good eye sight.

Core Competencies

  • Deciding and initiating action
  • Leading and supervising
  • Working with people
  • Adhering to principles and values
  • Presenting and communicating information
  • Applying expertise and technology
  • Analysing
  • Learning and researching
  • Planning and organising
  • Following instructions and procedures
  • Adapting and responding to change
  • Coping with pressure and setbacks

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Ad Visible Until: 7 July 2021
Ref: CPT000154/CH

Vacancy Type: Permanent