| 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 Sr. Manager, Doc Control and Product Release.
This position is responsible for the management of the Documentation Control/Product Release department and functions. Management of Documentation Control Management Personnel; Supervisor- Documentation Control, Supervisor-Product Review and Release, Documentation Control Technical Analyst; Sr. Systems Coordinator; Departmental Administrative Assistant.
Responsibilities:
Manages documentation system to assure specifications, batch records, SOP's, variances and MCA's are reflective of activities, applications and compliance with worldwide regulatory requirements.
Manages the finished product review/release function to assure compliance with good documentation practices, good manufacturing practices and standard operating procedures.
Manages ongoing review of documentation systems and functions and develops action plans for streamlining systems/functions to improve compliance and customer service
Manages the commercial, concurrent and scale product/process validations and assures they are completed and executed in a timely and accurate fashion
Manages the lot master module of the Oracle system and for the continuous upgrade of documentation systems including computer generated batch record and electronic documentation review.
Manages the proper maintenance and archival of all GMP related documentation
Manages technical product transfer documentation systems as required.
Manages departmental budget and personnel performance review programs
Work jointly with other site and corporate QA departments to develop corporate QA standards and policies.
Ensures all Documentation Control, Product Release and Label Control department activities are completed within established time frames required to meet company objectives.
Ensures all SOPs comply with compendial and regulatory requirements and guidelines.
Travel Requirements
As required up to 20% of the time
Qualifications:
Minimum 4-year degree in Science or Life Science field or equivalent work experience. Advanced level education a plus.
Advanced education in Science or Life Science field preferred.
Minimum 8-10 years of pharmaceutical or related work experience. Formal training with regards to cGMP regulations and requirements for the pharmaceutical industry. Experience in manufacturing processes (e.g. aseptic, terminal sterilization, API synthesis, device, solid dosage), validation (e.g. cleaning, facilities, equipment, processes, analytical methods) and quality systems. Knowledge of regulatory requirements such as 21 CFR 210 & 211. Computer knowledge in Word, Excel, Project and Access necessary. Strong written and verbal communication skills, specifically in technical writing communications and oral presentations.
Minimum 10-15 years of pharmaceutical or related work experience, and requirements as stated above.
Minimum 8-10 years experienced in specific pharmaceutical manufacturing including: sterilization, validation/quality systems and documentation preferred.
Excellent understanding of cGMP's and their importance in Documentation Control. Computer Literacy in standard software as well as some database management. Provides technical assistance to area supervisors or managers to solve complex problems.
Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results.
Must be able to interface with all levels of management, peers and subordinates. Remains calm, self controlled, and poised under all types of job pressure and responsibility.
Must have excellent written and verbal skills. Writes and speaks fluently, clearly and concisely. Is effective and confident communicating in a variety of settings both inside and outside of the organization.
Builds working teams with a focus on results. Develops effective and supportive relations with colleagues and subordinates to meet team goals.
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 10-5160.
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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