Production Pharmacist

1 week ago

Subang Jaya, Malaysia Pharmaniaga LifeScience Sdn Bhd Full time

Job Purpose:
Ensure that our products are manufactured and delivered to the customer on time, made at the best cost, safely and above all to the required quality standards for sterile products, fully compliant to regulatory requirements, right first time. Manage the team of production personnel to ensure that the facility operates according to the Quality Management System.

Job Responsibilities:

- Overall responsibility of production activities in meeting quality, productivity, targets, yield, cost and customer’s satisfaction.
- Responsible for GMP issues on premise, cleanliness, quality of product and equipment.
- To review all SOPs, Logbooks, Forms, Batch Manufacturing Record (BMR), Batch Packaging Record (BPR) are properly filled out on time in accordance to cGMP and GDP.
- To schedule and carry out training for production staff.
- To raise and close deviation and change control when necessary.
- To close audit findings in a timely manner.
- To be responsible for data key in on SAP & TrackWise system on time.
- To write the procedures and other documents relating to production operations and to ensure their strict implementation.
- To ensure that products are produced and stored accordingly in order to obtain the required quality.
- To complete and evaluate the production records and ensure that they are signed by an authorised person before they are sent to the Quality Department.
- To carry out the responsibility of a Head of Production in his or her absence.
- To ensure the appropriate validations are conducted on time.
- Perform process validation.
- The perform the monitoring and control of the manufacturing environment.
- Meet plant hygiene requirements.
- The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
- Documentation, monitoring, control and compliance according to standards implemented by Drug Control Authority for dangerous drugs and precursors.
- Communicate and coordinate with National Pharmaceutical Regulatory Authorities officers and inspectors.
- To coordinate and participate in relevant validation works pertaining to Production equipment and processes.
- To review and update the standard operating procedures and work instruction for Packaging areas to ensure they meet current practices and policies.
- To ensure the Packaging line meet the production schedule as outlined by the Head of Production.
- To ensure facilities and equipment in Packaging areas are well-maintained.
- To enforce safety working practices to all staff and contractors working in Packaging areas.
- To supervise activities associated with Packaging areas as well as Production areas.
- To ensure all equipment in Packaging areas are calibrated on time.
- To co-maintain equipment calibration master list for Packaging areas. To ensure strict implementation of aseptic behaviors in Packaging areas at all times.
- Authorized to supervise the mixing activity of DD (Dangerous Drugs), precursor and packaging process.

**Job Types**: Full-time, Permanent

**Salary**: RM5,500.00 - RM8,000.00 per month

**Benefits**:

- Dental insurance
- Health insurance
- Maternity leave
- Parental leave

Schedule:

- Monday to Friday

COVID-19 considerations:
Ability to commute/relocate:

- Subang Jaya: Reliably commute or planning to relocate before starting work (required)

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