Manager - Quality & Regulatory Affairs (5-7 yrs)
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.( ISO9000,188.8.131.52. 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.
- 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 .