Production Executive / Production Officer / Manufacturing Operator
About the Employer
Job Description
WE ARE HIRING!
PREMIUM INTERNATIONAL INJECTABLE (PVT) LTD Career Opportunity
We are a sterile Pharmaceutical Manufacturing Company looking for a young energetic individual with pristine qualifications and experience to take the lead in the following positions. The project is at the development stage and is located in Export Processing Zone, Koggala
Roles and Responsibilities
- Production Executive
Adhere to entry and exit procedures and maintain cleanliness in production areas and equipment
- Execute production plans to meet targets and manufacture products according to approved documents.
- Ensure accurate documentation and timely qualification, calibration, and maintenance of equipment.
- Monitor production activities, participate in equipment qualification, and enforce safety procedures. Escalate incidents or deviations to the Production Head and manage QMS activities.
- Support Environment Health & Safety policies and statutory compliance.
- Provide on-the-job training, monitor new processes/products, and coordinate with departments for production planning.
- Propose process improvements, investigate production issues, and optimize resource allocation for efficient operations.
- Ensure compliance with company policies and standards, exercise control over inventory, and assess production and resource requirements.
- Preparation, Revision & approval of BMR's, BPR's & SOP's.
- To prepare URS and review of all machine / equipment's / instruments related documents.
- To actively participate in execution of IQ, OQ, PQ of all machine / equipment's / instruments. Responsible for QMS activities like:
- Handling and review of incident, corrective action & Preventive action, change control, Investigation, Risk Assessment, deviation, market complaint, OOS, OOT, and APQR etc. and to ensure validation, qualification/requalification of equipment, calibration/recalibration of Instrument activities.
Qualifications & Requirement
- Bachelor of Pharmacy (B.Pharm) degree, or a degree in Pharmaceutical Sciences (Pharma)
- Master of Science (MSc) degree would be an added advantage
- Minimum 05 years' experience in the relevant field
- Exposure and experience in a Sterile Injectable pharmaceutical factory is preferred
- Expert and Subject Matter Expert (SME) in injectable formulation experience
- High level of computer literacy including MS Office Packages
- Should possess excellent communication skills in English (both Verbal and written)
- Production Officer
Roles and Responsibilities
- Adhere to entry and exit procedures and ensure cleanliness of the area and equipment. Execute production plans and escalate deviations to the Manager.
- Achieve production targets and maintain daily documentation.
- Manufacture products according to approved documents and ensure online entries are made. Ensure timely qualification, calibration, and maintenance of equipment.
- Monitor activities across various production sections and escalate incidents or deviations.
- Participate in equipment qualification and handle incident and corrective actions.
- Prepare and revise BMRS, BPRS, and SOPs, ensuring compliance with safety procedures.
- Support Environment Health & Safety policies and maintain compliance with cGMP.
- Assist Unit Head in achieving EH&S objectives and conduct inventory control.
- Assess production and resource requirements and adjust schedules for timely delivery.
- To actively participate in execution of IQ, OQ, PQ of all machine/ equipment's/ instruments.
Qualifications & Requirement
- Bachelor of Pharmacy (B.Pharm) degree, or a degree in Pharmaceutical Sciences (Pharma)
- Minimum of 3-5 years' experience in the relevant field is required.
- Exposure and experience in a Sterile Injectable pharmaceutical factory is preferred
- Expert and Subject Matter Expert (SME) in injectable formulation experience
- High level of computer literacy including MS Office Packages
- Should possess excellent communication skills in English (both Verbal and written)
- Warehouse Executive
Roles and Responsibilities
- Adhere to entry and exit procedures in the warehouse area.
- Ensure cleanliness of warehouse area, equipment, and instruments.
- Execute warehouse plans to achieve targets, including tasks like GRN preparation and material checking.
- Maintain online entries in BMR and relevant logbooks, and ensure timely qualification and maintenance of equipment.
- Participate in equipment qualification and execute safety procedures.
- Escalate incidents or deviations to the Production Head and oversee QMS activities.
- Support EH&S policies and statutory compliance in the warehouse department.
- Provide on-the-job training and coordinate with departments for warehouse planning.
- Investigate warehouse issues, determine resource requirements, and adjust schedules for timely delivery.
- Maintain inventory control and ensure compliance with company policies and safety standards.
- To prepare SOP, URS and review of all machine / equipments / instruments related documents.
- To actively participate in execution of IQ, OQ, PQ of all machine / equipments / instruments. Responsible for QMS activities like:
- Handling and review of incident, corrective action & Preventive action, change control, Investigation, Risk Assessment, deviation, market complaint, OOS, OOT, and APQR etc. and to ensure validation, qualification / requalification of equipment, calibration / recalibration of Instrument activities.
Qualifications & Requirement
- Bachelor of Pharmacy (B.Pharm) degree, or a degree in Pharmaceutical Sciences (Pharma)
- Master of Science (MSc) degree would be an added advantage
- Minimum 05 years' experience in the relevant field
- Exposure and experience in a Sterile Injectable pharmaceutical factory is preferred
- Expert and Subject Matter Expert (SME) in injectable formulation experience
- High level of computer literacy including MS Office Packages
- Should possess excellent communication skills in English (both Verbal and written)
Roles and Responsibilities
- Manufacturing Operator
Adhere to entry and exit procedures and maintain cleanliness of the area and equipment.
- Perform maintenance tasks on machines and their spare parts as required.
- Prepare disinfectant solutions and follow clean area practices.
- Document daily activities and ensure timely qualification, calibration, and validation of equipment.
- Participate in equipment qualification processes and execute preventive maintenance tasks.
- Clean and operate mixing and holding vessels, as well as CIP-SIP modules.
- Execute manufacturing area-related activities as instructed by the supervisor.
- Ensure proper labeling and storage of materials, as well as compliance with safety procedures.
- Follow SOPs and escalate any workplace hazards or incidents to supervisors and the EHS department.
- Provide support to senior staff as needed and ensure compliance with cGMP and other relevant regulations.
- Supervise contract workers, provide necessary PPE, and promote safe working practices.
Qualifications & Requirement
- Diploma in pharmacy, chemistry, biology, or a related field
- Possess minimum 03 years of hands-on experience in the manufacturing of generic or biotech products
- Expert and Subject Matter Expert (SME) in injectable formulation experience
- Basic communication skills in English
- Basic Computer skill
Work Location
Premium International Injectable (Pvt) Ltd, No: 1200, BOI Export Processing Zone, Koggala. The successful candidate would receive a competitive remuneration package and other benefits. If you meet the required criteria, please e-mail your CV, including contact details of two non-related referees to reach us within 07 days of this advertisement.
Head Office
Email: [email protected]
Premium International Injectable (PVT) Ltd
258, Havelock Road, Colombo 05.
Factory
Premium International Injectable (PVT) Ltd
No: 1200,
Board of Investment (BOI)
Export Processing Zone, Koggala.
