Specialist Quality Operations

Major accountabilities:

Key performance indicators:

• Have expertise in Supplier Quality management and QMS activities. Drafting of QRA, QAA and AMR documents. Handling Supplier Qualifications and change notification.

  Interpret and compile APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.

  Create and review GxP documents including SOPs, working procedures, trend reports, qualification

  reports and technical investigations, as and when needed.

  · Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports

  · Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows

  · Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables

  · Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required

  · Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements

  · Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers

  · Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes

  Requirements for the role

• Minimum 6 years of experience in Quality assurance activities in pharmaceutical company.
• GxP knowledge, Basic IT knowledge
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders

Minimum Requirements:
Work Experience:

• Functional Breadth.
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
• Collaborating across boundaries.
• cleanliness zones.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.