Quality Assurance – Responsibilities
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behaviour model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Batch Record Review & material release to ensure compliance with GMP requirements.
• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
• Carries out tasks related to the management of batch records design and approval.
• Carries out administration of the SAP Quality Management Module.
• Carries out tasks relating to the management of site change control systems.
• Compiles Annual Product Reviews.
• Supports all validation activities on site as described in the Site Validation Master Plan.
• Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
• Supports system qualification and process validation activities.
• Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
• Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
• Perform GMP audits on-site and vendor facilities as required.
• Carries out tasks related to the administration of site supplier approval process.
coordinating new launch shipments
• handling of product complaints
development, periodic review, revision and implementation of SOPs as required
• annual product reviews and review of stability reports for compliance with Canadian
• QA annual self-inspection and quality agreements with manufacturers, wholesalers and
conducting inspections of distributors and wholesalers as necessary per GMP requirements
acting as primary quality contact person with Third Party Logistics (3PL) and as qualified
person for internal quality compliance matters
implementing recall procedures if necessary
monitoring QA aspects of warehousing practices for compliance with warehouse procedure
manuals (Third Party Logistics-3PL)
liaising with customers and regulatory authorities regarding quality matters, including
hosting inspections and responding to observations.
• training of sales representatives on physician sampling handling and distribution
overseeing the maintenance and renewals of Drug Establishment Licence(s)
periodic GMP training for relevant staff
* Quality document checking for QP release.
* Support for QP batch release.
* Storing and retrieval of documents.
* Preparing batch release documentation, CoA and BRC.
* Updating CAPA, Change controls and deviations on QMS, general data entry.
* Closing off works orders after QP release using SAGE.
* Preparing documentation for MHRA audits.
* Handling customer complaints and enquiries, including medical product information, coordinate technical product complaint investigations.
* Handling and reporting of Adverse Drug Reactions / Adverse Events. Liaising with HPPV (third party Pharmacovigilance)
* Assisting contract manufacturers
* Attending daily production meeting
* Generating BPRS for manufacturing.
* Quality checking in production area, using excellent communication skills.
* Front line point of contact for company.
* Auditing and self-inspection.
* Primarily responsible for art work assessment and approval.
* Reviewing Technical Agreements
* Reviewing Pharmacovigilance Agreements with third country customers
* Be familiar with Eudralex Vol IV and other related directives
* Other related duties
a range of key primary and secondary duties to include:
- Manage the QMS to ensure its suitability and effectiveness and ensure non-compliance issues are addressed.
- Guide the QC team to identify needs and ensure development of SOPs for critical areas of operation and assess processes and suggest improvements based on assessed risk.
- Produce regular reports detailing the status of the QMS (CAPA, Recall, Regulatory, Complaints, Deviations, Change Control including developing trends) for dissemination to the Head of Quality (QA Manager), Production Management, Managing Director and Audit/Risk Committee.
- Manage the operation of the deviations and complaints processes
- Escalate the complaint investigations to the Qualified Person
- Review and close deviations and complaints as appropriate.
- Oversee and progress recalls and produce recall reports (in conjunction with Head of Quality) for regulatory bodies.
- Conduct recall effectiveness reviews
- Conduct internal audits of the QMS as per the defined audit schedule
- To be responsible for the Approval for Use (release) of all products manufactured or repackaged within Qualasept according to licensing requirements, GMP and professional discretion.
- Participate in any rota system that may operate within the product release team in order to deliver our service commitments.
- The development of activities and policies aimed at improving the effectiveness and efficiency of the service.
Tasks and Responsibilities:
* Performing internal audits to monitor compliance with the QMS and with Good Clinical Practice (GCP)
* Assessment of external suppliers and subcontractors via audit or questionnaire
* Co-ordination, guidance and review of quality issue investigations and CAPAs
* Involvement in regulatory inspections as required
* Writing, reviewing and approving SOPs
* Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP compliance
* Hosting customer audits of Quotient
* Delivering training programmes in Quality and GCP principles
* Maintenance and improvement of the company quality system as required
Main tasks and Responsibilities:
* Authoring, reviewing and approving key computer system validation documents
* Authoring, reviewing and approving incidents reporting as part of a validation project
* Providing technical validation support to operational colleagues
* Maintenance of validation documentation (paper-based and electronic)
* Conducting periodic reviews of computerised systems
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