Biological E - Head - Quality Assurance

Head Quality Assurance

Leadership Opportunity in Quality Assurance. Incumbent will be responsible to look after the entire QA activities of vaccine division as Head Quality Assurance. Interested candidates with 15+ years of experience in handling QA activities for sterile plants and must be at leadership role from last 5 years.

Brief Job Responsibilities :

Strategic Planning :

- Participate in Vaccine Quarterly Review Meetings and business planning meetings; provide inputs on product selection and prioritization, resource planning and structure redesign; formulate Quality strategy based on vaccine business strategy.

- In order to ensure alignment of Quality strategy and vaccine strategy to overall corporate strategy.

System Improvements and New Systems Implementation :

- Identify areas where new systems can be introduced and implemented such as Discrepancy Management System, Document Mapping Systems, etc; propose ideas to cross-GOFs and seek their feedback; gather data for due-diligence and prepare business case and present to Head Vaccines for approval; identify resources required for implementation; monitor progress of implementation; gather inputs from stakeholders post implementation and identify and act on areas of improvement.

- In order to ensure systems are capable of supporting and enabling growth in operations.

Discrepancy Management System and Change Control :

- Review DMS system periodically; analyze DMS reports to identify trends; analyze impact of critical discrepancies; review investigation reports and closure; evaluate all change control requests and CAPAs recommended by different teams; provide final approval along with other members of Global System Committee.

- In order to ensure the right CAPAs are initiated for incidents, discrepancies and NCs and only approved change requests are implemented.

Internal and External Audits :

- Review the audit plan; monitor conduct of internal audits as per the audit calendar; conduct audits on own team and other teams when required; act as audit host in due-diligence checks by partners, customer audits, QP, DCA, DCGI, MoH and other regulatory audits; drive the audit response process for NCs; monitor progress of closure of NCs and follow up with different teams when required.

- In order to ensure compliance of development, manufacturing and supply chain processes to regulatory requirements.

Product Release Support :

- 'Review campaign review reports prepared by Process Assurance teams; analyze trends w.r.t. to OOS, OOT; establish performance metrics to evaluate Operations, Performance and Governance (OPG reviews) of Process Assurance and Analytical Assurance team members.

- In order to ensure effective implementation of Process Assurance and Analytical Assurance processes.

Training :

- Analyze training needs of employees from a quality perspective; design training modules and conduct GCP, GLP, GMP and leadership training for employees across levels and functions

- In order to build the required awareness and competencies in employees to ensure compliance.

Facility Assurance & Commercial QA Support :

- Provide inputs to team members on facility structuring and project management tools and processes; introduce systems for conducting vendor qualifications including audit of their quality systems; provide sign-off on layout of facilities.

- Define process maps for identifying different stages where quality interventions are required; provide inputs to team member on SOPs, checklists and systems to be implemented for ensuring that the product quality and stability remain intact from the time it leaves the plant to the time it reaches the consumer.

- In order to ensure team members implement Facility, Development and Commercial Quality Assurance processes effectively.

Team Management :

- Participate in Union settlement discussions to put forth and negotiate on demands on work practices; conduct goal setting, performance appraisals and mentoring/coaching for own team members; collaborate with HR in manpower planning, recruitment activities and identifying training needs of team members; provide training to team members on new processes when required.

- In order to maximize retention and performance of team members.