Quality Control Jobs at ADVANZ PHARMA | Apply Now For The Senior Specialist – Quality Hypercare Role
ADVANZ PHARMA is hiring a Senior Specialist – Quality Hypercare (Biosimilars QC) at its Mumbai Centre of Excellence in Andheri (East). This hybrid role offers the chance to work with a global pharmaceutical leader dedicated to improving patients’ lives through specialty, hospital, and rare disease medicines. If you have expertise in biosimilars quality assurance and regulatory compliance, this is an excellent opportunity to contribute to advancing healthcare while building your career.
- Job Position: Senior Specialist – Quality Hypercare (Biosimilars QC)
- Location: Andheri (East), Mumbai 400, India (Hybrid)
About the Company
ADVANZ PHARMA is a global pharmaceutical company dedicated to enhancing patients’ lives by providing and improving specialty, hospital, and rare disease medicines. With headquarters in London, UK, and nearly 700 employees across more than 20 countries, including Canada, Australia, and India, ADVANZ PHARMA is a trusted partner for commercialization in the life sciences sector. The company’s Centre of Excellence in Mumbai drives innovation in biosimilars, specialty generics, and originator brands across multiple therapeutic areas.
Job Description
The Senior Specialist – Quality Hypercare (Biosimilars QC) will support the Associate Director, Biosimilars Quality, in managing all aspects of biologics/biosimilars quality. The role involves ensuring compliance with global regulatory expectations, overseeing the development and validation of analytical methods, and maintaining the Pharmaceutical Quality System for biosimilar products.
This position is ideal for professionals who thrive in dynamic environments, demonstrate leadership in quality assurance, and are passionate about advancing biosimilars and biologics to patients.
Key Responsibilities
- Maintain and enhance the Pharmaceutical Quality System for biologics/biosimilars.
- Support pipeline product assessments and strategic initiatives.
- Oversee QA activities to ensure the timely delivery of pipeline projects.
- Identify and resolve quality risks and hurdles that impact the project scope.
- Participate in regulatory interactions with EMA, Health Canada, TGA, and others.
- Provide QA oversight of analytical method development, validation, and transfers.
- Review protocols, reports, comparability studies, and bioassays.
- Resolve laboratory investigations and method performance issues.
- Approve deviations, CAPAs, and manage change controls.
- Perform risk assessments and lot disposition processes.
- Collaborate across functions while embodying ADVANZ PHARMA’s values of Entrepreneurship, Speed, and Integrity.
Qualifications
- Tertiary qualification in Life Sciences or Pharmaceuticals (advanced qualifications preferred).
- Proven subject matter expertise in biosimilars quality assurance.
- Strong experience in biopharmaceutical active substance production and analytics.
- Experience with EU regulatory guidelines, legislation, and scientific advice meetings.
- Broad understanding of biosimilar development and validation programs.
- Excellent communication, problem-solving, and leadership skills.
- Ability to thrive in fast-paced environments with tight deadlines.
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