Careers

Quality Engineer

Job Requirements

1. Fresh graduates or 2 years minimum experiance in related field.

2. Bachelor Degree In Sciences

3. Science related & basic statistical


Key Responsiblities

1. Report to the Senior Quality Engineer on matters pertaining to validation, quality system and control, and other related matters.
2. Train and supervise QA Technicians on validation activities and execution.
3. Perform IQ, OQ, PQ and process validation during the installation of new production equipment or as directed by change control procedure.
4. Responsible for equipment registration for new equipment and to maintain the equipment master list.
5. Responsible to conduct Process Validation and Cleaning Validation including preparation of documents, execution and compilation of validation data.
6. Assist in troubleshooting quality problems using the FMEA or similar tools.
7. Assist in performing risk analysis and providing proposals for the elimination or reduction of risks.
8. Responsible for supervising the monitoring of the manufacturing environment and utilities according to fixed schedule or when needed.
9. Plan and supervise the monitoring of Clean rooms, clean air devices, prepare protocols, review the data and prepare the reports.
10. Plan and supervise monitoring of manufacturing environments during the Start-up and Shutdown activities.
11. Responsible for initiating the in-house calibration request of monitoring and measuring devices used in Quality Assurance Department.
12. Responsible for monitoring and scheduling third party calibration of all Clean Air Device and Clean room Performance Test.
13. Ensure all activities are properly recorded and promptly documented and to comply with GMP and ISO requirements.
14. To work towards to achieve department KPI and provide support in internal audit, external audit and continual improvement plan.
15. Participate in any activities pertaining to training, safety, first-aid and fire-fighting organized by the company for the benefits of the staff and the company.

Interested candidates are invited to submit a detailed resume and completed Job Application Form and Application Questionnaire to:

Headquarters - Melaka,

Recruitment, Human Resource Department
Kotra Pharma (M) Sdn. Bhd. [198201010358 (90082-V)]
No 1, 2 & 3,
Jalan TTC 12,
Cheng Industrial Estate,
75250 Melaka,
Malaysia.

Tel : +606 - 336 2222
Fax : +606 - 336 6122
Email: hr @ kotrapharma . com


NOTE

1. Please write the name of position you are applying clearly on the top left of envelope or in the Subject of your email. Incomplete application will not be entertained.

2. Kotra Pharma has not engaged any representatives/agencies which requires potential candidates to pay any fee for interview arrangement.

Please DO NOT respond to interview offers from the following agency:

• Venus ManPower Services
Web: https://venusmanpowerservices.com/
Email: info@venusmanpowerservices.com

Careers

Quality Engineer

Job Requirements

1. Fresh graduates or 2 years minimum experiance in related field.

2. Bachelor Degree In Sciences

3. Science related & basic statistical


Key Responsiblities

1. Report to the Senior Quality Engineer on matters pertaining to validation, quality system and control, and other related matters.
2. Train and supervise QA Technicians on validation activities and execution.
3. Perform IQ, OQ, PQ and process validation during the installation of new production equipment or as directed by change control procedure.
4. Responsible for equipment registration for new equipment and to maintain the equipment master list.
5. Responsible to conduct Process Validation and Cleaning Validation including preparation of documents, execution and compilation of validation data.
6. Assist in troubleshooting quality problems using the FMEA or similar tools.
7. Assist in performing risk analysis and providing proposals for the elimination or reduction of risks.
8. Responsible for supervising the monitoring of the manufacturing environment and utilities according to fixed schedule or when needed.
9. Plan and supervise the monitoring of Clean rooms, clean air devices, prepare protocols, review the data and prepare the reports.
10. Plan and supervise monitoring of manufacturing environments during the Start-up and Shutdown activities.
11. Responsible for initiating the in-house calibration request of monitoring and measuring devices used in Quality Assurance Department.
12. Responsible for monitoring and scheduling third party calibration of all Clean Air Device and Clean room Performance Test.
13. Ensure all activities are properly recorded and promptly documented and to comply with GMP and ISO requirements.
14. To work towards to achieve department KPI and provide support in internal audit, external audit and continual improvement plan.
15. Participate in any activities pertaining to training, safety, first-aid and fire-fighting organized by the company for the benefits of the staff and the company.

Interested candidates are invited to submit a detailed resume and completed Job Application Form and Application Questionnaire to:

Headquarters - Melaka,

Recruitment, Human Resource Department
Kotra Pharma (M) Sdn. Bhd. [198201010358 (90082-V)]
No 1, 2 & 3,
Jalan TTC 12,
Cheng Industrial Estate,
75250 Melaka,
Malaysia.

Tel : +606 - 336 2222
Fax : +606 - 336 6122
Email: hr @ kotrapharma . com


NOTE

1. Please write the name of position you are applying clearly on the top left of envelope or in the Subject of your email. Incomplete application will not be entertained.

2. Kotra Pharma has not engaged any representatives/agencies which requires potential candidates to pay any fee for interview arrangement.

Please DO NOT respond to interview offers from the following agency:

• Venus ManPower Services
Web: https://venusmanpowerservices.com/
Email: info@venusmanpowerservices.com