Site Quality Head (PSS06773)

About the client: PSS has been mandated to hire a Site Quality Head for one of the largest Indian pharmaceutical companies.

Location: Sikkim/ Guwahati/ Other North/ North East Locations

Job Purpose:

The role involves ensuring the supply of GMP- compliant products by defining the strategy for quality system management at the site.

It includes setting QA and QC goals aligned with company compliance and regulatory requirements.

The individual provides leadership to meet all QA, QC, and stability accountabilities, proactively addressing quality issues and ensuring compliance with regulatory standards. They ensure the site is always prepared for inspections and audits, and maintain adherence to GxP regulations, training, documentation, and global quality policies.

Key Responsibilities:

Assess quality issues at the site and ensure compliance with QA/QC regulatory requirements in manufacturing operations at site.
Accountable for designing/implementing and ensuring compliance with all quality-related SOPs, Policies, Standards, and Quality systems at the site
Design and execute continuous improvement initiatives at the site to enhance compliance, and drive efficiencies, and cost-effectiveness.
Responsible for ensuring the availability of adequate resources, including manpower to maintain compliance with GXP requirements.
Facilitate harmonization and consistent implementation of Quality Systems and procedures at the site, in alignment with Global Quality policies/standards.
Ensure market complaints, failures, and deviations are investigated, and corrective and preventive actions are implemented with adherence to timelines
Assure all-time readiness of the 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 the Company’s and functions to leverage synergies.
Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements

Educational Qualifications And Experience:

BSc, Bpharma with around 20+ years of overall experience in Pharma.
Knowledge of GxP’s, cGMP and other regulatory requirements.