The role of Quality Operations Specialist at Sandoz is an excellent opportunity for professionals with experience in Quality Assurance, Regulatory Affairs, or Pharmaceutical Manufacturing. Below is a detailed summary of the position, responsibilities, candidate requirements, and additional information:
Position
Specialist – Quality Operations (GQS I)
Key Responsibilities
- Data Extraction & Analysis
- Extract data from Sandoz tools/applications.
- Interpret and compile external supplier APQR data and/or extracted internal data into predefined templates.
- Draft conclusions of product quality reviews.
- Coordination & Reporting
- Collect contributory reports for product evaluations.
- Interact with Contract Manufacturing Organizations (CMOs) and manufacturing sites.
- Support the updating and maintenance of the APQR schedule.
- Author, review, and approve APQR reports/data to ensure accuracy and completeness.
- Documentation & Compliance
- Archive approved APQRs and manage shopping carts for procuring supplier documents.
- Prepare and review analytical comparison reports as per EU or other regulatory requirements.
- Quality Management System (QMS)
- Participate in self-inspections, D2 ESOPs, investigations, QARP, and FURP as applicable.
Candidate Profile
- Educational Qualification:
- Pharmacy, Science, MBA, Engineering, or equivalent degree from a reputed institute.
- Experience:
- Minimum of 3 years in Quality Assurance, Regulatory Affairs, or manufacturing of pharmaceutical drugs, substances, or medical devices.
- Skills:
- Fluent in English (written and spoken).
- Strong communication, presentation, and interpersonal skills.
- GxP knowledge and basic IT proficiency.
- Experience collaborating with global stakeholders.
Job Details
- Location: Telangana (Sandoz)
- Industry Type: Pharma/Healthcare/Clinical Research
- End Date to Apply: 30th January 2025