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Quality Assurance Specialist

4 months ago

Wembley Greater London, United Kingdom Chemilines Group Full time

As a QA Specialist you will be responsible for improving our quality system, processes and procedures to assure products safety and quality, in line with the business and industry requirements. You will also support in RA as required to obtain and maintain granted license in swift and efficient manner.

Responsibilities

  • Provide full support in management of QMS. Drive the quality management review process, including data and reporting for Quality Management Review meetings.
  • Handle all Quality incidents/Deviations and prepare Quality/Incidents/Deviation reports as required. Ensure that IDRs are closed in a timely manner and ensure effective CAPA.
  • Supervise employees that update documents related to QMS.
  • Write/Review Standard Operating Procedures (SOP, s) for approval and authorization. Handle the date base for SOP.
  • Provide training on SOPs to staff members. Work with HR to create SOP training plan.
  • Handle complaints, returns recalls, CAPA and investigations. Retrieve reports from Navision, as required to support QA/QC investigation of Customer complaints or Product Recalls.
  • Prepare Risk assessments.
  • Conduct change control evaluation.
  • Conduct Self - inspection and provide Self-inspection report/Self inspection CAPA reports.
  • Inform appropriate internal departments on audit results and work with the necessary staff to achieve GMP &GDP compliance. Ensure the implementation of corrective actions that are raised by deviations, internal audit, or regulatory inspection.
  • Provide Navision and Nice label support. Support Equipment and process/ Software validation.
  • Complete audit of printing materials suppliers.
  • Attend Management review meetings and provide input as required.
  • Provide QA support during regulatory authority inspections, as applicable.
  • Carry out internal and external audits.

RA Responsibilities

  • Maintain effective control of the license portfolio, ensuring the licenses are up to date and comply with all regulatory requirements and trademarks.
  • Deal efficiently and effectively with MHRA, EMEA and other regulatory agencies for relevant regulatory policies and issues.
  • Review and authorize internal batch control documentation, including design of components for internal and external printing (Cartons, Labels, and patient leaflets) updating as required.
  • Ensure batch production records are generated as soon as the initial application or variation is granted and update electronic records accordingly.
  • Liaise with other departments, including production, quality assurance and purchasing, ensuring effective communication of all license statuses.
  • Support all aspects of trademark notification as required, including check samples, maintaining up to date knowledge of legal requirements and advising on specific requirements within the EU accession countries (e.g. Specific Mechanism)
  • Remain informed of current regulatory issues /matters as well as new developments, which may affect the company. Keep senior management team apprised accordingly.

Other Responsibilities

  • Assist junior staff with problem solving.
  • Train QA/RA team members in order to maintain the highest stand of quality and excellence.
  • Be a back up person for the QA/RA Manager
  • When QA/RA Manager is away, oversee the day-to-day management of the QA/RA tea, ensuring that work is allocated in a timely manner and completed to an excellent quality standard.
  • Participate in training as advised by QA/RA Manager
  • Participate in QA/RA projects as and when requested.

Skills & experience

  • Previous min. 5 year experience within a Pharmaceutical Industry, GMP/GDP environment and Quality Assurance
  • Proven experience working in quality control/assurance and/or regulatory assurance
  • Proven experience in Quality Management Systems (QMS) and ensuring continuous improvement
  • Experience with some or all of the following:
  • Deviations/Investigations
  • CAPA, complaints and recalls
  • Risk management plan
  • Experience in performing internal audits
  • Experience working with pharmaceutical supply chain
  • Experience in supplier/customer qualification, transport company qualification and transport validation
  • Competent in using Microsoft Office suite
  • Fluent English knowledge – both written and spoken

Competencies

  • Excellent communication skills – both written and oral
  • Accurate and precise
  • Attention to detail

The above is not exhaustive list of duties and you will be expected to perform different task as necessitated by your changing role within the organisation and overall business objective of organisation.