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Head - Corporate Quality - Pharma/Formulations

12.00 to 20.00 Years   Kolkata   28 Sep, 2022
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    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 yearsQualifications : Ph.D. or masters 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 CAPAs 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,

Keyskills :
solid oral dosage formsroot cause analysiscorporate quality assurance

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