| Job Description: |
Overview:
Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Quality Control Technical Writer and Reviewer.
The Quality Control Technical Writer and Reviewer will have primary responsibility for writing and reviewing laboratory protocols and reports. This individual will contribute to laboratory investigations, instrument qualifications , annual product reviews, method transfers/verifications, and commercial stability. Duties will include responsibility for reviewing laboratory data where needed.
Responsibilities:
Write Commercial Stability Protocols and Reports
Review and Write Method Transfer/Verification Protocols and Reports
Assistance in the writing of OOS investigations
Prepare Laboratory Deviation Reports
Write Instrument Qualification Protocols
Assemble QC Chemistry Annual Product Reviews
Contribute to internal audit, and regulatory audit responses
Review laboratory data
Travel Requirements
0-2 %
Qualifications:
Bachelor's degree in a life science or equivalent combination of education and related experience.
Bachelor's degree in Chemistry preferred.
4 - 6 years experience in a pharmaceutical laboratory or equivalent, including experience in HPLC/GC or a combination of a Master's degree and 2 years experience.
Familiarity with Statistical Analysis preferred.
Experience in Laboratory Equipment Validation preferred.
Experience with Laboratory Investigations
Basic computer skills. Knowledge and understanding of laboratory policies and GMPs.
Strong organizational and technical writing skills required
Knowledge of compendial and regulatory requirements,
Able to interpret and analyze data with minimal supervision. Able to compare testing data against existing procedures. Incorporate Technical expertise in report writing and review.
Demonstrates solid organization skills. Works to meet schedules or resolve problems
Interacts routinely with analytical chemists and lab management. Must be able to provide feedback with respect to data.
Must provide feedback to management regarding deadlines or questions regarding data. Is effective and confident communicating with managers in a variety of settings both in and out of the department.
Works independently with input from management.
As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.
Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com. Click Employment Opportunities, then Positions Available and search for Position 10-5228.
Resumes will be reviewed and qualified candidates will be contacted for pre-screening.
Search Firm Representatives Please Read Carefully:
Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.
Requirements See Job Description
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