Position: Provisionally Registered Pharmacist (PRP)

Work base: Cheng, Melaka

Job Outline:

1. To organize resources and activities required to produce pharmaceutical products in order to keep the smoothness of the operation and deliver quality products in timely manner.

2. To support the production team to enforce and raise GMP/ quality standard, productivity and indexes

Duties and Responsibilities:

Production:

To provide support in ensuring all production batches are manufactured in compliance with manufacturing instructions/ procedures and quality specification.
To support the coordination with supply chain personnel, plan, and control production manpower, production cycle time and manufacturing equipment to ensure production schedules are met with pre-determined productivity performance and efficiency indexes.
To adhere to production golden rules and ensure availability of materials, equipment, and documentation before commencement of production.
To ensure and maintain good housekeeping and 5S in production.
To support production management team to ensure that production goals are being met. To maintain primary communication of performance goals and requirements as identified by Production Management.
To assist in Engineering Department & ensuring maintenance of machines, equipment and tools are in good working order. Communicate with maintenance department regarding repair and preventive maintenance of machinery as required.
To assist the production management team doing the mentoring and supervise the production shop floor staffs and provide prompt support to staffs.
To support the production management team in establish training needs analysis and establish training plan for shop floor staffs.
To support the production management team in ensuring that production shop floor staffs are trained, evaluated accordingly and are capable of performing their jobs with knowledge, accuracy, and precision.
To support the production management team in establish, review, maintain or and improve the departmental standard operating procedures.
To support in collect, analyze data and information to determine paths for process improvement and identify potential root cause and take corrective actions in the case of non-conformity.
To carry out production or process changes upon approval. To monitor and control the outcomes of the changes based on recommended action / parameters.
To attend, participate, and conduct meetings including cross-functional meetings when needed.
To manage and review batch manufacturing record.
To report to department manager on departmental issues, activities, and accomplishments.
To assist I&D and TS department in new product development, re-engineering, qualification and process validation.
To prepare user requirement specification, installation qualification, operational qualification, and performance qualification protocol and reports. To perform qualification of process equipment through installation qualification / operation qualification / performance qualification and process validation.
To conduct certification and recertification of Designated Operating Staff based on Designated Operating Staff certification annual plan.
To review production log books on every month end.
To conduct investigation if there is any out of specification arises.
To write deviation report for planned and unplanned deviation.
To support production management team in ensuring that shop floor staffs are adhering to all safety procedures and identifying/communicating the necessary measures to address potential safety concerns.

Other Duties:

To attach to other departments such as QA, QC, RA, I&D, warehouse, Sales & Marketing according to the Provisionally Registered Pharmacist training module.
To perform assignment and project assigned by individual department.
To stay current with production processes and technology to continually improve productivity.
To supports company-wide continuous training and development program.
To perform any other duties as assigned to you from time to time.
ISOs Participation:

To participate in the improvement of Occupational Health and Safety Management System (OH&S).
Carry out work related to Occupational Health and Safety Management System (OH&S) as instructed.

Minimum Requirements:

Bachelor Degree in Pharmacy
Registered Pharmacist with the Malaysian Board of Pharmacy
Demonstrates good interpersonal skill and able to communicate with various levels in different department.
Demonstrate interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
Demonstrates good verbal and written communication skills.
Able to demonstrate strong professional writing skills and ability to prepare technical reports.
Have good ability in analytical and problem-solving skills.
Proficiency is required in Microsoft Word, Excel and PowerPoint.

Provisionally Registered Pharmacist

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