Site Quality Head - Quality Assurance - Pharma

Job Responsibilities :

Strong exposure for Regulatory Audits like: USFDA, MHRA, TGA, WHO etc

- 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

- Coordinating 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

- 18-22 years (5+ in injectable Formulations, with leading USFDA audits)

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