We are looking for a Corporate Quality Assurance Professional for a client based in International Location in the area of Solid oral dosage forms only. Experience : 12 - 20 years Qualifications : Ph.D. or master's degree in Pharmaceutical / Chemical Sciences 1. Experience in pharmaceutical products manufacturing for Highly Regulated & Semi-regulated markets. 2. Strong exposure for Regulatory Audits like : USFDA, MHRA, PIC/S, WHO etc 3. Experience of building a strong quality team & implementation of Quality Management System (QMS) at site/s. 4. Overviewing Quality operations in FDF manufacturing & R&D centre. 5. Monitoring & ensuring implementation of current GMP & GLP norms in Manufacturing 6. Unit of solid oral dosage forms & parenteral other dosage forms. 7. Proven capabilities of independent management of QA/QC Team with complete responsibility for Quality Compliance. 8. Training, framing the documentation for all the departments (SOPs / protocols, and various other cGMP records. Responsibilities : 1. Validation of process (Cleaning, Manufacturing / Packaging Process, Sanitization & Drainage), facility, equipment & systems (HVAC, Water System, Compressed Air system & Computerized System) 2. Quality Risk Management (QRM), change control, documents control, deviations, market complaint handling, product recall, product return, failure investigations & root cause analysis 3. Facilitation and closure of the CAPA's resulting from audits, investigations, failures, complaints and/or recalls; 4. Creating & updating APEX documents like Quality Manual, SMF, VMP & GMP Manual Facing different regulatory audits (USFDA, MCC, WHO& MHRA) 5. Maintenance of cGMP to the highest standards. 6. Reviewing & approving all the Quality documents. 7. Checking & ensuring appropriate calibration & validations of instruments / equipment are performed as per schedule. 8. Organizing GMP training for the team members in plant & R&D. 9. Coordinating with the Regulatory Affair Department to file CTD / ANDA / Dossier in various country and resolving the queries of the regulatory 10. Coordinating with Project Team for executing Green Field / Brown Field Projects on time Internal & external stakeholders for conducting new product assessments, quality and technical agreements 11. Customers for understanding the issues and conducting in-depth investigation & sustainable CAPAs 12. Conducting monthly reporting Cockpit and presenting the same to the management. 13. Monitoring & ensuring drugs are manufactured in safe & compliant manner and in accordance with the regulatory requirements defined by the Company, procedures and directives, relevant health authority submissions, CGMP and local Health & Safety requirements 14. Offering effective quality leadership during internal inspections 15. Participating in Internal as well as External Auditing Program

Overseas/International

Head - Corporate Quality  - Pharma/Formulations 

Head - Corporate Quality  - Pharma/Formulations  ,Job Description for Head - Corporate Quality  - Pharma/Formulations  in Cornerstone International Group in  Overseas/International for (12-20) years of experience. Apply Now!

Job Description for Head - Corporate Quality  - Pharma/Formulations  in Cornerstone International Group in  Overseas/International for (12-20) years of experience. Apply Now!