Quality Assurance and Regulatory Affair Manager- Bangalore

Our Client is UK Based leading Pharma Laboratories research and develops innovative, high quality solutions designed to make diagnostic testing quicker with higher accuracy and reliability for results of the highest quality. They are committed to saving lives by ensuring individuals worldwide have access to timely and correct diagnosis. Their products are used in over 145 countries worldwide by:

Their Products are used in Hospital Laboratories,Forensic Laboratories,A&E Units,Food & Wine Laboratories,Sports Organisations,Horse Racing Authorities,Veterinary Clinics,Pharmaceutical Companies,CRO Companies

Product Range

Biochip Analysers Biochip Immunoassays,Biochip Molecular Diagnostics,Cardiology,Clinical Chemistry Analysers,Diagnostic Reagents,Quality Control,RIQAS EQA,Disease States,Contract Manufacturing

  KEY TASKS & RESPONSIBILITIES:

1)     Plan and manage departmental activities in accordance with agreed budgets and timescales.

2)     Manage departmental performance against agreed targets and budgets, and within policies and standards.

3)     Manage staff according to company standards (appraisals, discipline, training, development).

4)     Contribute to executive policy and strategy.

5)     Develop and implement Policies to ensure compliance with National and International Quality Regulations and Harmonised Standards.

6)     Monitor and inform/communicate/apply standards created/maintained by external bodies and integrate within the internal quality management system.

7)     Develop and maintain systems to establish standards relating to activities and products.

8)     Develop and implement effective Post Market Surveillance and Vigilance procedures.

9)     Develop and maintain a good communication strategy for the improvement and awareness of quality issues across all departments.

10) Develop and maintain systems to measure performance against established standards.

11) Monitor performance according to agreed standards and take necessary action to communicate/advise/assist according to performance levels.

12) The review of specifications and standard operating procedures.

13) The control of the master documentation system and quality records.

14) The performance of internal quality system audits.

15) The chairing of the Quality Management Review meetings.

16) The management of effective environmental control.

17) The control and review of the design, development and validation process for new products.

18) The development of systems to ensure that all suppliers consistently meet company specifications so enabling product satisfaction.

19) The development of quality systems in conjunction with OEM partners to ensure customer satisfaction.

20) The implementation of waste packing management systems.

21) The control of existing trademarks and registration of new trademarks.

22) The registration of products as required on a world-wide basis.

23) Liaise and co-operate with quality management and standard bodies.

24) Ensure that all team members are working in accordance with company Health and Safety procedures and maintaining a safe working environment.

If this Job post intrestes to pl mail your profiles along with the revelent details to mailto:jasmin@crystalconsultants.in

 

Crystal Consultants

Hyderabad

040-23412218-19/9866178034