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Night Aseptic Production Supervisor

Pfizer
Jakarta, JK
28 days ago: Pfizer

Job Description

POSITION DESCRIPTION
-- To be completed by Manager -
+ Position Description Resource Guide (Guide is also available through hrSource search)
+ Hiring Manager Toolkit
For US/PR, unless otherwise noted, all fields must be completed.
Identifying Position Information
POSITION TITLE:
(title reflected in Outlook and Pfizer Org Chart)
NIGHT ASEPTIC PRODUCTION SUPERVISOR
REPORTS TO: (Manager's Name & Title)
Production Manager
DATE COMPLETED/ REVIEWED
04 Mar 2017
DIVISION/BUSINESS LINE:
Pfizer Global Supply
SUB DIVISION:
BioPharma Ops & Ex Supply
DEPARTMENT: (number & name)
Production Operations
LOCATION(S): (indicate all possible locations)
Jakarta
IS THIS A LEGACY HOSPIRA POSITION?
☐ Yes
Global Job Structure Information
(for assistance, see the GJS Navigator )
JOB CODE: (see GJS Navigator tool)
606692
GLOBAL JOB STRUCTURE ATTRIBUTES:
(Job Function, Job Sub Function, Job Family, Career Track, Career Track Level, Global Job Level)
Job Function: Manufacturing
Job Sub Function: Manufacturing
Job Family: Drug Product Manufacturing
Career Track: Technical Operations
Career Track Level: Team Leader
Global Job Level: J060B
Grade Information
(may not be applicable outside the US/PR)
LOCAL GRADE:
SALARY PLAN:
Please complete below if role will be posted
POSTING TITLE:
(title you want applicants to see, if different than position title; include shift hours )
ASEPTIC PRODUCTION SUPERVISOR
POSITION NUMBER(S):
POSTING DETAILS:
☐Internal
☒ Internal & External
\# OF VACANCIES:
RELOCATION AVAILABLE:
☒ Yes
☐No
INTERNAL CANDIDATE IDENTIFIED:
☐ Yes
REQUISITION JUSTIFICATION:
☐ New Job/Position
☒ Replacement
☐ Reorganization
Prev. Incumbent's Name:
enter text
☐ Acquisition
☐ Secondment
☐ Student
To be completed by Global Compensation (US/PR only)
Compensation Evaluation required for new or revised roles; work with your HR Generalist to obtain compensation review.
DATE OF COMPENSATION EVALUATION:
REVIEWER INITIALS:
NOTES:
ROLE DETAILS
Please provide definitions for all acro nyms. For US/PR, unless otherwise noted, all fields must be completed.
ROLE SUMMARY
Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region). Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
+ To effectively and efficiently establish a work plan of the compounding/mixing, aseptic filling process based on the monthly production from Materials Management
+ To ensure that the bulk products and sterile primary packaging released by Quality Control (QC) and Quality Assurance (QA) for aseptic filling is done in compliance with relevant GMP principles, Pfizer Quality Standards, and regulations set forth by Food and Drug Administration of Republic Indonesia (BPOM)
+ To ensure that the compounding/mixing process, aseptic filling process, and secondary packaging process are done using appropriate components
+ To ensure that the line clearance, cleaning, and sterilization processes of the facilities, equipment, minor tools, gowning, disinfectant, tubing, filter, and product pathway, are done as procedure.
+ To ensure that the aseptic operator are skilled with aseptic behavior when working in aseptic area and perform manual simulation
+ To ensure that all production activities were appropriated documented properly.
+ To ensure that the appropriate pre-caution are taken in all production processes and work method to maintain occupational safety and health.
+ To ensure that production equipment and facilities are clean, orderly placed in proper location and area safety operable to achieve the objective of safe, reliable, and operable condition together with Engineering support.
+ To ensure the optimal utilization of all packaging and other resources relation to packaging operations and to seek ways to enrich the potential of mentioned resources.
+ To ensure production is scheduled in order of priority for finished products as defined by the Material Management.
+ Create and Review Batch Record, SOP, Job Aid, Visual Board, Job Function Curricula (JFC), OJT (On-The-Job) Documentation, Manufacturing Investigation Record/Incident (MIR), Quality Assurance Report (QAR), Event Record (ER), Quality Risk Assessment (QRA) using FMEA, Change Control/Change Request, Event and Form Logbook-Checklist.
+ Control budget and amount of non-inventory stock for production supplies.
+ Train New-Employee and/or for Operators/Supervisor for GMP procedure related.
+ Conduct continuously improvement by using M1 and M-2 Projects, Zero Defect Project, Kaizen project for Production Improvement.
+ Escort the Auditor during visit in Site for Compounding, Aseptic Filling Area for Primary Packaging and Secondary Packaging Area.
+ Evaluate of environmental monitoring trend result as opportunity for improvement as preventive action to avoid the environmental monitoring excursion.
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
+ Supervising daily sterile production & packaging activities.
+ Assuring all sterile products are processed and packed according to Good Manufacturing Practices (GMP), Pfizer Quality Standards (PQS) and regulatory and statutory requirements.
+ Providing sterile finished products in time as required by PPIC.
+ Re-checking and receiving raw materials from dispensing before used in sterile production process to assure it correctness.
+ Developing specific Manufacturing Procedures (MP) and Packaging Instructions (PI).
+ Developing Standard Operation Procedures (SOP) of machine, cleaning, handling etc. to meet GMP and PQS requirements.
+ Preparing and appropriate investigation on sterile product/ process out of specification (OOS) and sterile product complaint/ re-call to find the root causes, provide solution, and prevent the recurrence.
+ Assuring the sterilized materials availability for sterile production.
+ Providing monthly report to Production Manager on monthly achievement i.e., sterile product supply, process problem (re-work, complaint, recall), documentation index, and other projects.
+ Conducting gap analysis of the approved PQS and develop specific actions to fulfill the PQS requirement.
+ Conducting GMP and machine/ aseptic process training to Team Leaders, Operators, and Packers.
+ Actively involve in Right First Time initiatives in sterile production and packaging activities.
+ Actively involve in validation/ qualification activities.
+ Actively involve in new product launch.
+ Actively involve in environmental, health & safety (EHS) program.
+ Actively involve in BPOM audit and CQAA.
+ Preparing the plan to purchase manufacturing supplies and capital expenditure (machine investment) during budget preparation for sterile process and packaging activities.
+ Assuring the sterile production and packaging areas, machine, and facilities in good condition and tidy.
+ Preparing sterile production planning/ schedule based on product supply requirement.
+ Developing cost improvement program (CIP) in sterile activities.
+ Encouraging colleagues to rise up their ideas/ innovative to find a better operation.
+ Conducting annual self-appraisal and evaluating Team Leader/ Operator/ Packer performance.
+ Actively involve in ISO 9001:2008 programs.
QUALIFICATIONS
Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
Education
Pharmacist
Experience
At least 3 years experience in manufacturing or validation on pharmaceutical industries, experience in sterile manufacturing would be an advantage.
Technical Competencies
Computer literate
Able work well either as individual or as a team member
Creative
Having good leadership
Having good communication skill
PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)
Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
Can work under pressure and working more than 12 hours per day (if needed).
Can work at drug product manufactory environment
Can work at aseptic processing area environment
No Color blindness
Can standard mathematical calculations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
(not all roles will have non-standard work schedule travel, or environment requirements)
Include any work schedule, travel or environment requirements necessary for the performance of the role. Types of requirements might include ability to work particular hours (shift, overtime), travel or adhere to safe work practices and procedures such as aseptic gowning. Any criteria indicated must be job-related, consistent with business necessity, and specific to this role.
This position are working under shift rotation and it is possible to work overtime.
DEPARTMENT MARKETING STATEMENT
(not required - only use language approved by leadership)
Include any department specific information explaining group's makeup, purpose, accomplishments (never include specific names of colleagues within the company/group)
N/A
OTHER INFORMATION - INTERNAL ONLY
(not all roles will require information to be posted in this section)
Include any information pertaining to internal colleague only; section will be used by Talent Acquisition to note Global Job Level information when applicable.
N/A
CORE COMPETENCIES (Applicable only for the Senior Leader or Manager roles and global job levels indicated below)
Select the 3-5 competencies most critical for the successful performance of this role from the appropriate Pfizer Core Competency set below. Please only choose selections from appropriate section.
Supervisor
Global Job Level J060. (Aseptic Production Supervisor)
☒ Problem Solving
☒ Build Relationship
☒ Strategic & Innovative Thinking
☐ Customer Service Orientation
☒ Planning & Organizing
☒ Communication Skill
☒ Decision Making
☐ Know The Business
☒ Delegating
☒ Initiatives
☒ Coach & Develop Others
☒ Drive for Result
☒ Teamwork
☒ Adaptability/Flexibility
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.
Internal
Report to Production Manager
External
+ Contact with PPIC, Warehouse, QC and QA and etc regarding production and product supply activities.
+ Contact with Engineering regarding machine maintenance/ problem, calibration, utility supply, and house keeping.
+ Contact with Technical Services regarding validation & qualification activities.
+ Contact with HR Personnel Departement regarding temporary/ casual employee requirement, benefits, outing, ect
+ Contact with sterilizer contractor regarding packaging materials sterilization process.
+ Occasional contact with Purchasing and supplier regarding purchased material & material complaint.
+ Occasional contact with EHS regarding environment, healt & safety program
RESOURCES MANAGED
Financial Accountability
Control budget of supplies for sterile manufacturing processes within 1 - 2 Billion Rupiah.
N/A
Supervision
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
This position will have subordinate consist of
+ 3 Team Leader
+ 3 Line Setter
+ 71 Operators
This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
POSITION DESCRIPTION -- To be completed by Manager - + Position Description Resource Guide (Guide is also available through hrSource search)+ Hiring Manager ToolkitFor US/PR, unless otherwise noted, all fields must be completed. Identifying Position Information POSITION TITLE: (title reflected in Outlook and Pfizer Org Chart)NIGHT ASEPTIC PRODUCTION SUPERVISOR REPORTS TO: (Managers Name & Title)Production Manager DATE COMPLETED/ REVIEWED 04 Mar 2017 DIVISION/BUSINESS LINE: Pfizer Global Supply SUB DIVISION: BioPharma Ops & Ex Supply DEPARTMENT: (number & name)Production Operations LOCATION(S): (indicate all possible locations)Jakarta IS THIS A LEGACY HOSPIRA POSITION? ☐ Yes Global Job Structure Information (for assistance, see the GJS...