West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
Job Summary:
- This position supports the production to perform quality inspection in the compounding process, molding process and the finished goods to meet the quality required by the customer.
Our main goal is to deliver products that are cost effective, but without jeopardizing the required standard of performance, reliability and quality.
All employees should at all times perform their activities in accordance with the quality policy of the company
Essential Duties and Responsibilities:
To focus on all the quality requirements for all products /production process run in the compounding and molding section, including in-process inspection, off line inspection and documentation.
Perform quality inspection on compounding production per established quality specification.
Perform quality inspection on molding production per established quality specification.
Finish goods to perform AQL inspection.
Track and record production and rejection data.
Perform documentation verification e.g. batch card, rework forms, scrap forms as per the SOI.
To comply the cGMP always.
Lab equipment validation, maintenance and calibration.
Feedback to Supervisor /QA Manager any problems on process deviations and quality issues which are beyond your control.
Prepare and revise testing SOI related with Compounding Lab and AQL Lab.
Sample, test, record and release of Incoming material per requirement.
Be responsible for retention samples of FG.
Conduct any other job assigned by QA head and direct supervisor
Education and Experience:
With at least 1 years of working experience in Quality department as QC.
Knowledge, Skills and Abilities:
Quality:
Be aware of the special responsibility for quality and conducts activities in accordance with the Company Quality policy at all times.
Work to c GMP standards as required by the company.
Ensure good ‘5s’ and housekeeping are maintained at all time in the work areas.
Ensure that products confirm to the requirements of our customers and meet full customer satisfaction.
Ensure products that are cost effective without prejudice to the required standard of performance, reliability and quality.
Ensure results are documented in accordance to cGMP and procedure
Ensure proper labeling of approved, rejected and on-hold parts.
- SOP:
Be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Safety:
Be aware of his/her special responsibility towards health and safety in accordance
with the company’s safety policy at all times;
Work safely by not causing unsafe conditions or doing unsafe acts
Proper use of Personal Protective Equipment (PPE)
Ensure all safety features are check and tested according to the requirements before start the
Operation.
Promptly report any malfunction safety features to the Superior immediately for corrective action.
Adhering to the process and procedures that apply to Health and safety conformance.
- Lean:
Support and contribute actively in Lean Sigma programs and activities towards delivery of the set target.
Ensure that 5S in QC final is maintained.
Simplify processes and improvements after approval from QA-Manager; reduce printing or photocopying; use recycle papers where possible
- Take initiative to reduce waste by switching off machinery if not in operating for a prolong period (e.g. Weekend / public holiday etc.)
Support lean sigma initiatives and actively participate in waste reduction and quality improvement.
Competencies/Authorities
Good communication skill, with team work spirit
Good computer skill
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to peggy.tayloe@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
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