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Premium Employer

Sun Pharmaceutical Industries

Compare

4.0

based on 5.7k Reviews

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

1 Sun Pharmaceutical Industries Head Site Quality Job

Site Quality Head

SUN PHARMA

4.0

based on 5.7k Reviews

20-25 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Site Quality Head

Sun Pharmaceutical Industries

posted 28d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy EHS Continuous Improvement GMP Quality Systems

Job Description

POSITION SUMMARY

Ensure the supply of high quality, GMP compliant products, define operational strategy for quality system management at site, finalize site quality assurance and quality control goals, objectives and strategies in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.

Provide leadership and direction to ensure achievement of all site accountabilities for QA, QC and Stability at site. Proactively assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at the site and track quality assurance/control metrics with site manufacturing and drive them down. Assure all time readiness of site for regulatory agency inspections\internal audits at any given point

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

Assess quality issues at site and ensure compliance to QA/QC regulatory requirements in manufacturing operations at site and track quality metrics with site manufacturing management and drive them down.
Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and Quality systems at the site.
Design and execute continuous improvement initiatives at the site to enhance compliance, drive efficiencies and cost effectiveness.
Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
Facilitate harmonization and consistent implementation of Quality Systems and procedures at site, in alignment with Global Quality policies\standards.
Ensure market complaints, failures, deviations are investigated and corrective and preventive actions are implemented with adherence to timelines.
Assure all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams.
Monitor industry trends/issues faced internally and identify scope for improving Site quality management and processes.
Ensure compliance to regulatory requirements on product, process and release procedures.
Prepare site quality revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
Responsible for ensuring smooth collaboration with all Sun Pharma sites and functions to leverage synergies.
Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements