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Premium Employer

Sandoz

Compare

4.0

based on 420 Reviews

430 Sandoz Jobs

Specialist Quality Operations

Sandoz

4.0

based on 420 Reviews

6-8 years

Hyderabad / Secunderabad

1 vacancy

Specialist Quality Operations

Sandoz

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Agile Coaching PLM Teamcenter Process Improvement Service Level Management

+ 1 more

Job Description

Provide quality support in compliance with cGMP requirements and Novartis Quality Management System. Manage Quality aspects & projects within area of responsibility.

Job Description

Major accountabilities:

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

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.

Skills Desired

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

Employment Type: Full Time, Permanent

Read full job description

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