Quality Manager

2 weeks ago

india Talenture Group Full time
Job Description
My Client, a top company in the pharmaceutical sector is seeking a Quality Manager whose main responsibility will be to ensure products manufactured and imported are consistently of high quality, efficacious and safe for patients in line with company’s internal requirements whilst complying with requirements of NAFDAC and WHO cGMP guidelines.
He/She will be responsible for the overall management of Quality Assurance and Quality Control activities in the business, and work with the technical director to develop and implement departmental strategic goals and objectives. Other key responsibilities include:
  • In-charge of product Batch release in line with cGMP Guidelines (NAFDAC andWHO).
  • Ensures qualification of all plant & quality control equipment, validation of manufacturing processes, cleaning processes and analytical methods are planned for and subsequently carried out according to the VMP.
  • Ensure that Quality Control and IPC testing are carried out using validated methods before release of any product.
  • Ensure proper investigation of all products related Customer Complaints and deviations, according to WHO cGMP guidelines.
  • Maintenance of the Company’s quality policy and ensure the cascade to all new and existing staff.
  • Review, of the site master file in conjunction with other stakeholders as required.
  • Ensure GMP related trainings are carried out in line with the approved training plan and procedure.
  • Ensure routine self-inspection and preparation of the business for all external audits.
  • Management of recall of products, out of specification results and deviations as well as change control.
  • Ensure management of stability studies via periodic evaluation of the results of accelerated and follow up stability studies.
  • Manage annual product quality reviews activities.
  • Prepare and manage the departmental OPEX and CAPEX ensuring that expenses are kept within acceptable limits.
  • Ensure that product and promotional artwork are well proofread having the right placement of logo and colour conformances on materials before final approval and release.
  • Certify that all new products developed meet defined product requirement as well as participate in products developed by the Company or third party.
  • Conduct at least an annual quality management review meeting.
  • To ensure in liaison with other stakeholders for the destruction of rejected materials or products in line with NAFDAC regulations.

Requirements
  • B.Sc. in Pharmaceutical, Physical Sciences and other science relatedDisciplines.
  • Computer literacy and Microsoft Office Proficiency.
  • Minimum of 8 years practical experiences in pharmaceuticals with a minimum of 5 years in the same capacity as Quality Manager with knowledge of WHO cGMPguidelines.
  • Quality Management Skills.
  • Managerial and People management skills.
  • Auditing skills, critical evaluation skills.
  • Data Analysis, Report Writing and Presentation skills.

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