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QA Senior Specialist

QA Senior Specialist

cGxPServeBoston, Texas, USA
7 days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Ensure distribution licenses (where required) accurately reflect the current organization vary license where necessary.
  • Support recalls mock recalls and any other onmarket activity.
  • Serve as QA assessor / approver on Change Controls : resolve gaps approve change plans classifications strategy for GDP / GMP actions.
  • Support the GDP Management Review process; Review and assess the risk of inputs such as metrics regulatory intelligence and identified risks and gaps; Recommend mitigation approaches.
  • Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments e.g. QMS build out Distribution licenses (or equivalent) application audits and Quality Agreements.
  • Planning / Preparation / supporting / hosting for Regulatory inspections.
  • Providing front and backroom inspection support.
  • Post inspection followup with responses and CAPAs (Continuous improvements).
  • Manage / Approve / Assess event investigations deviations (including Fast Track deviations).
  • Manage CAPAs and Effectiveness Checks.
  • Perform other duties as per GDP guidelines and company policies and procedures.
  • Work with companys Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved.
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that selfinspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned rejected recalled or counterfeit medicines including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
  • Create / review and approve Standard operating Procedures and other Quality Documents.

Requirements :

  • Bachelors in a scientific or allied health field and relevant GDP & GMP work experience or relevant comparable background.
  • 5 years experience serving in a Quality role.
  • Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
  • Influencing skills in areas with no direct reporting authority.
  • Strong interpersonal and communication skills.
  • Auditing skills appropriate qualifications in auditing an advantage.
  • Fluency in English is required.
  • Proficiency in using Microsoft Office applications required (MS Word MS Excel MS PowerPoint)
  • Serve as QA assessor / approver on Change Controls : resolve gaps approve change plans classifications strategy for GDP / GMP actions
  • Preparation and maintenance of Quality Agreements.
  • Review of deviations CAPA and changes.
  • Maintaining KPIs.
  • Analyze resolve or assist in solving compliance and customer issues.
  • Escalation of issues.
  • Finish Goods Release at 3PL.
  • Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS.
  • Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
  • Working collaboratively with key internal stakeholders.
  • Support Clinical QA Distribution.
  • GDP.
  • Distribution.
  • Logistics.
  • Industry experience.
  • Good Group fit.
  • QA background.
  • QMS CAPA.

    • Key Skills

    Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

    Employment Type : Full Time

    Experience : years

    Vacancy : 1