Offers “Abbott”

Expires soon Abbott

Administrative Employee

  • Olst-Wijhe, Nederland
  • Marketing

Job description

JOB DESCRIPTION:

Summary:

The Sterile and Oral Production departments are responsible for the formulation, filling and packaging of a range of world-wide distributed, commercial Pharmaceutical Products.

The Administrative Employee conducts activities on a daily basis as described in the applicable Job Descriptions.

The Administrative Employee is responsible to comply with:

1. All internal (Abbott&Olst) & external EHS&E regulations. Production activities must be performed under safe conditions, while the health of the technicians has to be guaranteed and negative effects on the environment have to be prevented.

2. All internal (Abbott&Olst) & external Quality requirements. Production must comply with rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these rules and regulation

Knowledge:

1) Technical or laboratory education, MBO 3 or equivalent

2) Proficient in Dutch, both in oral and written communication

3) At least 3 years of work experience in comparable industry

4) Experience with MS Office Applications (Excel, Word etc.) and SAP

Competences:

Quality minded, Result oriented, Anticipate, Planning & Organizational skills, Proactive

Key activities:

1.1 Execute order preparation within the batch record and SAP system (e.g. PI sheet in SAP)

1.2 Timely staging of materials of upcoming materials

1.3 Review of departmental batch records and logbooks

1.4 Reconciliation of materials, physically as well as paper based and/or electronically in SAP.

2.1 Keeps departmental stocks at the right level, and checks and takes appropriate actions at end-of-month reconciliation.

2.2 Line performance data such, minor stops, 5 minute charters are registered in appropriate computerized systems (e,g. Excel files OEE toolkit)

2.3 Men and machine hours are checked and registered in SAP.

3.1 Supports at performing line clearances when qualified

3.2 Supports at delivering personnel planning

3.3 Plans, monitors and timely communicates to operators required execution of training/qualification activities, e.g. GMP/EHS&E qualifications in Isotrain and BHV training.

3.4 First point of contact for organisational issues (e.g. double checks process, resolving planning's issues in case of illness) in case of absence of Shift Supervisor. Hierarchical responsibilities will not be transferred to the Administrative Employee.

Gen Other departmental administrative tasks, not related to 1.x and 2.x, can be tasked to the Administrative Employee.

Mission, purpose: he/she will ensure that…

1. All GMP related administrative handlings related to batch preparation & reconciliation, batch record review and data registration in appropriate documentation and/or computerized systems (e.g. SAP) are executed.
2. All non-GMP related administrative handlings related to material stock levels, line performance data and other data registrations are appropriately recorded in the applicable computerized systems.
3. Operational teams are supported during temporarily absence of Shift Supervisor

Performance indicators

a. RFT batch records
b. # Non-conformances related to human error
c. OEE losses due to poor staging of materials

JOB FAMILY:

Manufacturing

DIVISION:

EPD Established Pharma

LOCATION:

Netherlands > Olst : OAA/OAB

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

Make every future a success.
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