Opening For Pharmaceutical Quality Assurance Global Talent Pool

15.0 - 20.0 years

45 - 50 Lacs

Bengaluru

Work from Office

01 Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units. 02 Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development. 03 Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews 04 Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints) 05 Making sure that critical deviations are investigated and resolved; 06 Approving all specifications and master production instructions, Test methods, Qualifications 07 Approving all procedures impacting the quality of intermediates or APIs 08 Making sure that quality related complaints are investigated and resolved 09 Adhering to QA budget. 10 To qualify company for various certifications. 11 Assuring QMS in all Units. Experience 15 - 20 Years Salary Not Disclosed Industry Pharma / R&D / Biotech Qualification B.Pharma, M.Sc Key Skills Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance

Posted 1 day ago

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Assistant Manager - Billing and Onboarding (RCM) Vision Unlimited

8.0 - 13.0 years

8 - 12 Lacs

Mohali

Work from Office

Oversee billing workflows, billing accuracy, compliance with payer and regulatory guidelines. SME in Practice Mgt (PM), Billing, PM software, payer portals, clearinghouses. POC & supports project mgt for billing onboarding for new practices in RCM

Posted 2 days ago

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Deputy Manager Quality Assurance & Regulatory Affairs Acharya Group

12.0 - 20.0 years

10 - 18 Lacs

Dombivli

Work from Office

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments. Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan. Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3). Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries. Oversee training programs for plant personnel and ensure continuous adherence to GMP standards. Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable. General Requirements: Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.). Strong analytical, documentation, and decision-making skills. Proficient in regulatory submissions and quality review documentation. Familiarity with stability studies and establishing expiry/retest periods. Hands-on experience with validation protocols and equipment calibration systems. Ability to lead cross-functional teams and ensure site-wide compliance. Excellent verbal and written communication skills. Willingness to take ownership and drive continuous improvement initiatives.

Posted 3 days ago

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