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Careers

Compliance Executive

Job Requirements

  • Bachelor's Degree, Post Graduate Diploma, Professional Degree, Engineering (Chemical), Engineering (Industrial), Engineering (Bioengineering/Biomedical), Science or equivalent.
  • At least 1 year experience this field.
  • Fresh graduate are encouraged to apply.
  • Strong analytical, planning and organisational skills, with an ability to plan and priorities effectively and to work in a busy environment.
  • Excellent communications and interpersonal skills are required, with an ability to communicate effectively with partners and staff at all levels.
  • Excellent computer skills. A self starter, with a high level of motivation and an ability to act on his/her own initiative.


Key Responsiblities

  1. To assist and report to Assistant QA Manager (AQAM) in executing and running the daily affairs related to Production Operation Section including but not limited to the handling and closure of Change Control, Deviation, Out of Specification (OOS), Customer Complaint and Product Recall.
  2. Responsible for the implementation of Quality Management System in accordance to current Good Manufacturing Practices based on PIC/S, ISO and other requirements outlined in pharmaceutical industry.
  3. To assist in effective implementation of quality system and lead to continual quality system improvement.
  4. To participate in all internal / external audit, such as follow up for closure of audit findings and closely monitor CAPA effectiveness within Compliance (Production Operation Section).
  5. Ensure Logbooks, Trending and SOP related to Compliance (Production Operation Section) are up to date.
  6. Assist to administer and follow up with Compliance Executives and clerks for their assigned tasks, including special project as well.
  7. To oversee the performance for all staffs (including executives and clerk / senior clerk) within the section.
  8. Foster teamwork by actively participating in and supporting work environment that cultivates professional growth among the staff.
  9. To adhere to company rules and regulation and adopt quality policy as well as safety policy as part of working culture
  10. To resume responsibility of the Assistant QA Manager in the absence of AQAM or otherwise authorized.
  11. To execute all other matters & task assigned by QA Manager / Assistant QA Manager.

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

Headquarters - Melaka,

Physical submission to:

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

or

Submit digitally through:

Email: hr @ kotrapharma . com


NOTE

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

2. Please be informed that Kotra Pharma has not engaged any agencies that require potential candidates to make any payment for interview arrangements for all positions advertised or offered.

Careers

Compliance Executive

Job Requirements

  • Bachelor's Degree, Post Graduate Diploma, Professional Degree, Engineering (Chemical), Engineering (Industrial), Engineering (Bioengineering/Biomedical), Science or equivalent.
  • At least 1 year experience this field.
  • Fresh graduate are encouraged to apply.
  • Strong analytical, planning and organisational skills, with an ability to plan and priorities effectively and to work in a busy environment.
  • Excellent communications and interpersonal skills are required, with an ability to communicate effectively with partners and staff at all levels.
  • Excellent computer skills. A self starter, with a high level of motivation and an ability to act on his/her own initiative.


Key Responsiblities

  1. To assist and report to Assistant QA Manager (AQAM) in executing and running the daily affairs related to Production Operation Section including but not limited to the handling and closure of Change Control, Deviation, Out of Specification (OOS), Customer Complaint and Product Recall.
  2. Responsible for the implementation of Quality Management System in accordance to current Good Manufacturing Practices based on PIC/S, ISO and other requirements outlined in pharmaceutical industry.
  3. To assist in effective implementation of quality system and lead to continual quality system improvement.
  4. To participate in all internal / external audit, such as follow up for closure of audit findings and closely monitor CAPA effectiveness within Compliance (Production Operation Section).
  5. Ensure Logbooks, Trending and SOP related to Compliance (Production Operation Section) are up to date.
  6. Assist to administer and follow up with Compliance Executives and clerks for their assigned tasks, including special project as well.
  7. To oversee the performance for all staffs (including executives and clerk / senior clerk) within the section.
  8. Foster teamwork by actively participating in and supporting work environment that cultivates professional growth among the staff.
  9. To adhere to company rules and regulation and adopt quality policy as well as safety policy as part of working culture
  10. To resume responsibility of the Assistant QA Manager in the absence of AQAM or otherwise authorized.
  11. To execute all other matters & task assigned by QA Manager / Assistant QA Manager.

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

Headquarters - Melaka,

Physical submission to:

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

or

Submit digitally through:

Email: hr @ kotrapharma . com


NOTE

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

2. Please be informed that Kotra Pharma has not engaged any agencies that require potential candidates to make any payment for interview arrangements for all positions advertised or offered.