Asst. Manager QA and Regulatory

ARKRAY; Surat; On-site; INR 900,000 - 1,200,000; Full time

Job summary

A pharmaceutical company located in Surat is seeking a Quality Assurance Executive/Manager with a minimum of 6-8 years of experience in quality assurance and regulatory practices. The ideal candidate will have knowledge of quality techniques and must be proficient in English. Responsibilities include monitoring quality control systems, conducting internal audits, and supporting the Quality Head in the effective implementation of QMS.

Qualifications

• Minimum 6-8 years of experience in Quality assurance and regulatory.
• On-job knowledge of in vitro MDD / IVD documentation.
• Experience with IVD/medical devices / injectables in Executive / Managerial position.
• 6-8 years in QA and regulatory, with IVD/medical devices exposure preferred for executive/managerial roles.
• Strong written and spoken English.

Responsibilities

• Monitor Implemented Quality Control Systems.
• Provide training wherever required.
• Conduct Internal audits at regular intervals.
• Coordinate Batch failure and OOS Investigations ensuring proper CAPA.
• Qualification and Validations of facility, equipment and processes.
• Participate in Vendor development and audits for materials.
• Support Quality Head in QMS implementation.
• Support in maintain effectiveness of established strategic vision for the Quality Assurance.

Skills

Quality assurance techniques

Good written and spoken English

Computer proficiency (MS Excel, PPT, Word)

MS Excel

PowerPoint

Word

Education

Graduate and/or Post Graduate (Pharmacy, Biochemistry, Biotechnology, Chemistry)

Tools

MS Excel

PPT

Word

Job description

Min experience of 6-8 years in Quality assurance and regulatory. Graduate or Post Graduate.

Requirements

• Graduate and/or Post Graduate (Pharmacy, Biochemistry, Biotechnology, Chemistry.)
• Knowledge of techniques involving quality assurance of pharmaceuticals antibodies/ Proteins
• On-job knowledge of in vitro MDD / IVD documentation
• Min experience of 6-8 years in Quality assurance and regulatory with preferably IVD/medical devices / injectable in Executive / Managerial position.
• Innovative thinking for solutions of problems arising out of established Quality Management System, Leader
• Good written and spoken English
• Computer proficiency (MS Excel, PPT, Word)

Duties and Responsibilities

• Monitor Implemented Quality Control Systems
• Provide training wherever required
• To conduct Internal audits at regular intervals
• Coordinate Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions (CAPA).
• Qualification and Validations (Revalidation) of facility, equipment and processes
• Participate in the Vendor development and audits for raw materials and packing materials
• Support Quality Head in QMS and its effective implementation.
• Support in maintain effectiveness of established strategic vision for the Quality Assurance

Office Location

Surat

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