Head - Quality Assurance - Pharma (12-20 yrs)
We are looking for a 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.
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
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.