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
MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS
Science and Pharmacy Graduates or Equivalent
15 years in a pharmaceutical quality management leadership roles experience preferred.
REQUIRED SUCCESS ATTRIBUTE
- Knowledge of GxP’s, cGMP and other regulatory requirements.
Planning and Prioritization
Collaboration
Accountability
Compliance
Customer Service orientation
Secondary Success Attributes
- People Connect
Attention to detail
Emotional control
Effective Communication & Problem solving
Roles
Additional responsibilities can be assigned as required.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.
DELEGATION OF RESPONSIBILITY
In the absence of job holder, delegation of responsibility will be as follows:
Upward Delegation – Strategic site responsibilities to higher level
Downward Delegation – Operational responsibilities to direct reports or similar job role