Quality Head

Job Objective:

Head Quality is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.

We prefer candidate from Sterile Ophthalmic/ Injectable industry

Role & responsibilities :

• Leadership & Team Management
• Result Orientation &Multi Tasking
• Good Communication Skills
• Develop, implement, manage, audit and maintain GMP quality systems.
• Coordinate and perform all vendor qualification and compliance audits.
• Develop, manage and maintain a GMP compliant document control system.
• Oversee investigations of all non-conformances (deviations, errors etc.).
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the company
• Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
• Provide quality guidance to product development projects and programs.
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
• Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially
• Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies
• Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of EU GMP/ etc
• Managing all validation activities, including validation strategy and approval of protocols and reports
• Develop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise
• Ensure qualification & maintenance of equipment's, department & premises
• Ensure optimum utilization of the resources available so as to comply with the agreed timelines with customers, internal & external.
• Ensure - ZERO- down-time for want of maintenance of machines, manpower & material
• Observing and complying with GLP.
• Represent QA at senior management, project, Board, and review meetings.
• Providing direction and guidance to the Quality team.
• Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
• Identifying and developing the Quality team structure.
• Preparing and justifying the Quality department's budget.
• Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
• Budgetary and managerial responsibility for Quality Assurance and Quality Control

KEY PERFORMANCE INDICATORS:

(Indicate how performance will be measured: indicators, Key result areas)

• Audit Compliance
• Market Complaint
• Cost of Quality
• Leadership