Careers

Production Line Manager

Job Requirements

1. 3 years of working experience in pharmaceutical industry

2. Bachelor's Degree in pharmaceutical science/ pharmacy or equivalent

3. Basic science, pharmaceuticals, chemistry, physics and etc


Key Responsiblities

1. Responsible to oversee all aspects of operation in each production line under his / her assignment to facilitate System Optimization specifically and to administer overall production management generally. He / She is positioned to manage out-of-expectation (OOE) in the event of utilities interruption or man power shortage and to attend to any other matters / functions which are not addressed by his / her subordinates.
2. Report to Operation Manager, in his/her absence report to Production Pharmacist or Production Manager or Assistant Production Manager on all matters pertaining to daily manufacturing, packing & filling operations in the Non-Sterile Production or Sterile Production, depending on the assignment.
3. Adhere strictly to approved company procedures, plant and personal hygiene practices, protective clothing or gowning requirement as well as safety precautions aligned with current Good Manufacturing Practices (cGMP) and safety requirement.
4. Employee is liable to convey to Operation Manager if his/her subordinates (Namely Line Assistant, Line Technician, Line Supervisor or Line Executive) and himself/herself suspects of affected by an infectious disease or having open lesions or wound on the exposed surface of the body before entering in manufacturing area.
5. Employee is also liable to observe and ensure that his / her subordinates observe the rules of cross-contamination prevention at every stage of processing where products and materials to be protected from microbial and contaminants of highly sensitizing or highly active materials, contaminants from residues on equipment and from his/her clothing
6. Liable to observe the escalation pathway in communicating any deviation, out of specification or any out of expectation incidence or occurrence pertaining to dispensing, manufacturing, filling & packing operations to Operation Manager and higher, to Quality Control Department or to Quality Assurance Department. If deviation occurs, employee shall required to follow the necessary Standard Operating Procedure to ensure a written approval of a competent person is obtained, with the involvement of the Quality Control or Quality Assurance Department when appropriate before continuing the intended process.
7. He / She is also liable to ensure his / her subordinate enforce Good Documentation Practice in verifying entries records in either Batch Manufacturing Records, Batch Filling Records or Batch Packing Records or other forms or log books used to serve as documented evidence of conformance to Good Manufacturing Practices principle based on PIC/s guidelines and Quality Management System based on ISO 9001. Employee is liable to train his / her staff on the compliance of GDP.
8. He / She is also responsible to cascade down “need to know” information to his / her subordinates. In addition, he / she need to ensure his / her subordinates aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
9. Employee is required to plan weekly/ monthly schedule with Operation Manager and oversee daily line execution in respective production line.
10. To enforce Line Utilization and Line Efficiency are updated correctly to present the performance of each line.
11. To ensure the product traceability is maintained throughout the entire production.
12. Ensure the department head counts utilization is at optimal level and to ensure no manpower resources are wasted due to redundancy caused by poor planning.
13. To liaise with Material Management (MM) to optimize production planning schedule and to ensure MM Manager is being informed if there is any significant deviation on the planned output. He / She is also required to recommend suitable remedy to ensure supplies of goods are not interrupted.
14. To assist Operation Manager on arrangement for annual personal appraisal performance to his/her subordinates.
15. Oversee the occupational safety and health of his / her staff and the entire operation of the assigned line. When working with dry materials and products of highly active or sensitizing nature, the employee must exert special precaution to prevent the generation and dissemination of dust.
16. Maintain self-discipline, integrity, commitment, work with customer oriented, passion and team spirit. Strive for self development and keen to acquire new knowledge or skill.
17. Employee is required to check the production batch records after reviewed by Line Executive.
18. Responsibility for LINE MANAGER ONLY
18.1. Employee is responsible to monitor yield for both production output of finished product and also the production efficiency. Yield for product output below specification and production line efficiency of below expectation will need to initiate investigation and reports to Operation Manager.
18.2. Authorize to arrange the manpower resources at optimal level and to approve/ reject all leave application from his/her subordinates in order to avoid disruption on the line caused by poor planning of manpower. Employee also authorizes.
18.3. To arrange OT and/or Shift Arrangement and submit to Production Manager for approval.

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

Production Line Manager

Job Requirements

1. 3 years of working experience in pharmaceutical industry

2. Bachelor's Degree in pharmaceutical science/ pharmacy or equivalent

3. Basic science, pharmaceuticals, chemistry, physics and etc


Key Responsiblities

1. Responsible to oversee all aspects of operation in each production line under his / her assignment to facilitate System Optimization specifically and to administer overall production management generally. He / She is positioned to manage out-of-expectation (OOE) in the event of utilities interruption or man power shortage and to attend to any other matters / functions which are not addressed by his / her subordinates.
2. Report to Operation Manager, in his/her absence report to Production Pharmacist or Production Manager or Assistant Production Manager on all matters pertaining to daily manufacturing, packing & filling operations in the Non-Sterile Production or Sterile Production, depending on the assignment.
3. Adhere strictly to approved company procedures, plant and personal hygiene practices, protective clothing or gowning requirement as well as safety precautions aligned with current Good Manufacturing Practices (cGMP) and safety requirement.
4. Employee is liable to convey to Operation Manager if his/her subordinates (Namely Line Assistant, Line Technician, Line Supervisor or Line Executive) and himself/herself suspects of affected by an infectious disease or having open lesions or wound on the exposed surface of the body before entering in manufacturing area.
5. Employee is also liable to observe and ensure that his / her subordinates observe the rules of cross-contamination prevention at every stage of processing where products and materials to be protected from microbial and contaminants of highly sensitizing or highly active materials, contaminants from residues on equipment and from his/her clothing
6. Liable to observe the escalation pathway in communicating any deviation, out of specification or any out of expectation incidence or occurrence pertaining to dispensing, manufacturing, filling & packing operations to Operation Manager and higher, to Quality Control Department or to Quality Assurance Department. If deviation occurs, employee shall required to follow the necessary Standard Operating Procedure to ensure a written approval of a competent person is obtained, with the involvement of the Quality Control or Quality Assurance Department when appropriate before continuing the intended process.
7. He / She is also liable to ensure his / her subordinate enforce Good Documentation Practice in verifying entries records in either Batch Manufacturing Records, Batch Filling Records or Batch Packing Records or other forms or log books used to serve as documented evidence of conformance to Good Manufacturing Practices principle based on PIC/s guidelines and Quality Management System based on ISO 9001. Employee is liable to train his / her staff on the compliance of GDP.
8. He / She is also responsible to cascade down “need to know” information to his / her subordinates. In addition, he / she need to ensure his / her subordinates aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
9. Employee is required to plan weekly/ monthly schedule with Operation Manager and oversee daily line execution in respective production line.
10. To enforce Line Utilization and Line Efficiency are updated correctly to present the performance of each line.
11. To ensure the product traceability is maintained throughout the entire production.
12. Ensure the department head counts utilization is at optimal level and to ensure no manpower resources are wasted due to redundancy caused by poor planning.
13. To liaise with Material Management (MM) to optimize production planning schedule and to ensure MM Manager is being informed if there is any significant deviation on the planned output. He / She is also required to recommend suitable remedy to ensure supplies of goods are not interrupted.
14. To assist Operation Manager on arrangement for annual personal appraisal performance to his/her subordinates.
15. Oversee the occupational safety and health of his / her staff and the entire operation of the assigned line. When working with dry materials and products of highly active or sensitizing nature, the employee must exert special precaution to prevent the generation and dissemination of dust.
16. Maintain self-discipline, integrity, commitment, work with customer oriented, passion and team spirit. Strive for self development and keen to acquire new knowledge or skill.
17. Employee is required to check the production batch records after reviewed by Line Executive.
18. Responsibility for LINE MANAGER ONLY
18.1. Employee is responsible to monitor yield for both production output of finished product and also the production efficiency. Yield for product output below specification and production line efficiency of below expectation will need to initiate investigation and reports to Operation Manager.
18.2. Authorize to arrange the manpower resources at optimal level and to approve/ reject all leave application from his/her subordinates in order to avoid disruption on the line caused by poor planning of manpower. Employee also authorizes.
18.3. To arrange OT and/or Shift Arrangement and submit to Production Manager for approval.

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