CAPA MANAGER [ ISKANDAR PUTERI ]
Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 10,000.00 – 15,000.00
Posted Date : August 23, 2019
- The Quality and Compliance CAPA Manager supports implementation and management of CAPA processes and metrics for department within COMPANY
- This position assists with coordination, management, and reporting of CAPA processes to ensure department objectives are being met
- This position will work with members within the CFT as well as others outside CFT to completing CAPA investigations and actions, advise on proper documentation and root cause analysis, and provide oversight on timely completion of activities.
- This position will oversee CAPA activities associated with internal quality issues and those associated with audit and inspections. This position may also be required to perform other quality activities based on business need.
- Work with CAPA record owners to complete CAPA work on time and provide guidance on proper CAPA processing, including root cause analysis and identifying appropriate actions, to ensure it complies with company procedures and policies.
- The scope of this includes internal quality issues and observations received from audits and inspections. Create or edit CAPA procedures and training material as required. May deliver Quality Issue and CAPA training to staff as required.
- Gather CAPA data and provide Quality issue and CAPA process metrics to management. Create new metrics as needed to evaluate work and the health of the process within Company
- Prepare and Participate in cross functional CAPA Review Board Meetings to maintain on time completion of CAPAs. May chair meetings as needed and lead others through influence
- Minimum of 5 years experience in the pharmaceutical / biopharmaceutical industry, medical device, or life sciences required
- Knowledge of Quality systems and processes is preferred.
- Knowledge of CAPA processes and experience performing and leading CAPA investigations is required.
- Must have demonstrated experience of influencing others to achieve results and be able to prioritize tasks independently
- Must have good communication skills.
Kindly contact the following consultant at 07-2305453 for further details or send your resume to Mr Hanafi [ firstname.lastname@example.org ] / Ms Valli [ email@example.com ]