The head of Quality Assurance and regulatory affairs is responsible for Management of Quality personnel within the quality department. The quality department is responsible for the following functions: Regulatory Affairs, Quality Assurance, Final Batch release and incoming inspection. Documentation Control, Validation and production line clearance.

Job Description :

- Key member of the operation management team and corporate quality team.( ISO9000,4.1.2.3. ISO9001,5.5.2), ISO 13485.

- Keep up to date of current quality manual including preparation, revision and execution.

- Control of the quality manual including preparation, revision and execution.

- Responsible for organising management review and compiling and reporting on the performance of the quality system.

- Ensuring that all the customer specific quality requirements are compiled with the following contract review.

- Management of the product review and release system and signature on certificates of conformity & COA.

- Management of change control and document control systems.

- Issuing, control and filing of all batch related documentation.

- Responsible for final sign-offs on all product labels, package inserts and marketing material.

- The organisation of product and facility inspection, preparation and procedures and instructions in including certification assessment and surveillance audits, notified body/ FDA/CDSCO inspections, other regulatory inspections and supplier audits.

- Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product.

- The management of non conformance and corrective and preventive action and systems including the control of further processing and delivery of non- conforming product until any deficiencies or unsatisfactory conditions have been corrected .

- Responsible for coordination of issuing products safety notifications or product recalls as well as medical device reporting( MDR) with the CEO.

- Ensure latest updates of regulatory requirements are implemented and available for use and communicated to other facilities in BIOSENSE.

- Key participant in design control.

- To communicate the awareness of customer requirements throughout the organisation and to champion quality and continuous improvement initiatives.

- To liaise with external parties on matters of the quality management system.

Education & Experience :

- Degree ( Science), Engineering, Business discipline or equivalent inn terms of relevant operational experience.

- 5-7 years + industrial experience +3 years or more in the IVD industry or similar industry is required.

- Experience in project management of change management of change programs.

- First-hand experience of audits by regulatory authorities.

- Experience in hosting and leading CDSCO and other regulatory authority audits, would be an advantage.

- Extensive experience of developing and delivering effective training on quality system and processes.

- Demonstrated track record and success in team building skills.

- Demonstrated experience of people management.

Skills :

- Logical, Planned approach to all tasks, Excellent communication skills, interpersonal skills, team focused.

- International standards, GLP, GMP,

- Manage complex projects, multiple functions.

- Ability to gain consensus on key quality/ operational decisions.

- Strong analysis/problem solving skills.

- Strong attention to detail/ quality focus.

- Balanced cost / quality/ customer focus.

- Willingness and ability to collaborate with and influence other group in a positive.

- Team- based environment. Must also be able to hold others to account as required

- Work with the sense of urgency and have the ability to be impartial and objective

- Be an active learner and developer for of self and others with excellent organisational skills .

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