Site Quality Head
Level : Head Site Quality Assurance--One of the fastest growing pharmaceutical company
Role/Department : Site Quality
Education : Graduate / Post Graduate
Experience : 15-18 years
Job Location : Paonta Sahib
Job Responsibilities :
- Monitoring & ensuring implementation of current GMP &GLP norms in Manufacturing Unit of parenteral and solid oral dosage forms.
- Conducting internal audit as per USFDA, MHRA, TGA, MCC & WHO-GMP requirement
- Facing different regulatory audits (USFDA, MCC, WHO& MHRA)
- Preparing & implementing Quality Management System (QMS)
- Training, framing the documentation for all the departments (sops / protocols, and various other cGMP records.
- Proven capabilities of independent management of QA/QC Team of 70+ with complete responsibility for Quality and Regulatory Compliance.
- Creating & updating APEX documents like Quality Manual, SMF, VMP & GMP Manual
- Engaged in :
- Validation of process (Cleaning, Manufacturing / Packaging Process, Sanitization & Drainage), facility, equipment & systems (HVAC, Water System, Compressed Air system & Computerized System)
- Quality Risk Management (QRM), change control, documents control, deviations, market complaint handling, product recall, product return, failure investigations & root cause analysis
- Facilitation and closure of the CAPA's resulting from audits, investigations, failures, complaints and/or recalls
Maintenance of CGMP :
- Managing GMP / GLP Quality Assurance Investigations
- Reviewing & approving all the GMP documents
- Checking & ensuring appropriate calibration & validations of instruments / equipments are performed as per schedule.
- Organizing GMP training for the team members in the plant
- Co-ordinating with the Regulatory Affair Department to file CTD / ANDA / Dossier in various country and resolving the queries of the regulatory
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
- Customers for understanding the issues and conducting in-depth investigation & sustainable CAPAs
- Conducting monthly reporting Cockpit and presenting the same to the management
- 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
- Offering effective quality leadership during internal and regulatory inspections
- Participating in Internal as well as External Auditing Program
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