Quality Assurance Manager
2 days ago
About the Role
">Our organization is seeking an experienced professional to assume a senior-level Quality Assurance position. The ideal candidate will have extensive experience in managing quality assurance processes and ensuring compliance with regulatory requirements.
">Key Responsibilities
">- Managing audits for regulatory agencies, including USFDA, EMA, and CDSCO;
- Maintaining technical knowledge of regulatory and cGMP requirements;
- Assessing and monitoring Quality Management Systems (QMS) at manufacturing sites and R&D functions;
- Holding industry software experience like TWD, SAP HANA, LIMS, DMS etc.,
- Reviewing Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc. - QMS;
- Handling Customer Quality agreements and coordinating with cross-functional teams;
- Tracking CQA SOPs as per review date;
- Preparing/Revising CQA SOPs and making master SOP list effective after completion of training;
- Reviewing Master formula and technology transfer documents for API sites;
- Providing training on SOPs, cGMP, or other modules as required;
- Reviewing SOPs related to various departments;
- Scheduling and participating in self-audits (Sites and corporate functions);
- Supporting regulatory and customer audits at sites;
- Reviewing Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites;
- Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries;
- Participating in Quality-related meetings;
- Ensure that Quality Management System meets all the requirements and regulations.
Requirements
">We are looking for individuals with:
">- Bachelor's degree in Pharmacy/Master's degree in Pharmacy or Science;
- Minimum 13-17 years of experience in Quality Assurance, preferably in the pharmaceutical industry;
- Strong understanding of regulatory requirements and Quality Management Systems;
- Excellent communication and leadership skills;
- Able to work independently and collaboratively as part of a team.
About Our Organization
">We are a leading player in the pharmaceutical industry, committed to delivering high-quality products and services to our customers. We strive to create a workplace that fosters growth, innovation, and excellence.
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