Job Detail



Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Master Degree
Professional Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 10,000.00 – 15,000.00
Posted Date : August 23, 2019

Job Responsibilities

  1. The Quality and Investigation Manager supports investigation of deviations, OOS/OOT, complaints etc. in line with established QMS procedures within COMPANY
  2. This position assists with coordination, investigation, management, and reporting of issue investigation and processes to ensure department and site objectives are being met
  3. This position will work with members within the CFT as well as others outside CFT to complete required investigations and actions, advise on proper documentation and root cause analysis, and provide oversight on timely completion of activities.
  4. This position will oversee investigation activities associated with internal quality issues and those associated with deviations, OOS/OOT, complaints etc. This position may also be required to perform other quality activities based on business need.
  5. Work with owners of deviation, OOS/OOT, complaints etc. to ensure all investigations are conducted in a structured manner towards root cause identification in a timely manner and provide guidance on appropriate CAPA and identifying appropriate actions, to ensure that all activities comply with company procedures and policies.
  6. The scope of this includes investigations on all internal quality issues and complaints.
  7. Create or edit investigation procedures and training materials as required. May deliver communication on Quality Issue and investigation training to staff as required.
  8. Gather investigation data and provide Quality issue and investigation process metrics to management. Create new metrics as needed to evaluate work and the health of the process within Company
  9. Prepare and participate in cross functional Investigation Review Board Meetings to maintain on time completion of investigations. May chair meetings as needed and lead others through influence.
  10. Perform other quality and compliance activities as required including supporting audits and inspections.


  1. Minimum of 5 years experience in the pharmaceutical / biopharmaceutical industry, medical device, or life sciences required
  2. Knowledge of Quality systems and processes is preferred.
  3. Knowledge of investigation processes and experience performing and leading investigation is required.  
  4. Ability to use various investigation tools is an advantage.
  5. Must have demonstrated experience of influencing others to achieve results and be able to prioritize tasks independently. 
  6. Must have good communication and organisation skills.

Kindly contact the following consultant  at  07-2305453 for further details or send your resume to Talent Resource Unit [ ] / Mr Hanafi  [ ]