Quality Laboratory Manager

Description:

Extensive knowledge of quality management systems and quality improvement tools, working knowledge of standards, practices, and guidelines, and Analytical Skills. Excellent verbal and written communication skills, Excellent organization skills, Ability to analyze and interpret written information and scientific data to compare against established requirements, identify potential discrepancies, and make suggestions for improvement, Knowledge of applicable safety requirements. Knowledge of laboratory equipment, related supplies, collaborative, Ability to manage a budget and work within the constraints of that budget. Effective document management and technical bench skills Strong problem-solving, training, team building, and mentoring abilities Strong documentation and process follow-up skills.

Key Responsibilities

1.      Direct and coordinate all aspects of the Laboratory's quality assurance and quality control programs.

2.      Create and maintain quality assurance manuals for various laboratory certifications

3.      Monitor quality assurance data and manage internal and external audits and respond to audit findings

4.      Ensures all laboratory staff are trained in critical requirements of quality control

5.      Serves as key liaison with regulatory/audit bodies regarding inspection activities including attending inspections and preparation of responses to written inspection reports

6.      Ensure compliance with laboratory safety and security standards set forth by ISO 15189 and other regulatory bodies

7.      Manages programs and activities within the quality assurance functions of an organization.

8.      Administers policies and programs ensuring that organizational services and processes meet established quality standards.

9.      Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate the quality of raw materials or components, in progress goods, processes or operations, and implement and measure the impact of corrective actions.

10.   Solicits internal and external feedback with the goal of continuously improving processes or products.

11.   Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and

commission of analytical and microbiology instrumentation. Ensure there are efficient instruments for the workload of samples.

12.   Assure adequate communication of priorities exists between the lab and other departments and within the lab. Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.

13.   Evaluate referral lab and supplier.

14.   Enforce and ensure that prompt corrective action is taken with respect to laboratory audit findings or deficiencies noted with regard to implemented quality programs.

15.   Establish a control system on quality. Ensure that continual improvement is going on after implementing the system.

16.   Ensure compliance with PNAC & JCI standards and guidelines.

17.   Establish control over documents and data including documents of external origin (such as examination procedures etc.)

18.   Prepare a yearly plan for quality assurance and follow the quality assurance requirements.

19.   Schedule and arrange internal audits on the basis of the status and importance of the functions. Review and finalize the actions taken by the auditee as a basis to resolve nonconformities.

20.   Conduct data analysis and identify fruitful results for further improvement. Identify the corrective and preventive action based on the analysis of errors.

21.   Establish and improve procedures and processes by addressing issues and risks.

22.   Ensure the lab establishes and maintains a calibration program for testing equipment that affects quality results.

23.   Ensure that environmental requirements are met as per the requirement of the regulatory body

24.   The job responsibilities listed are not exhaustive and should also include any responsibilities as assigned by HOD/ management.

Qualification

MSc – MLT with relevant Quality Assurance/ ISO Standards Diploma

Experience

2 to 5 Years of Proven Experience with PNAC & JCI standards and processes.