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Quality Manager with Pharmaceutical CGMP
Ref No.: 18-00623
Location: Phillipsburg, New Jersey
Position Type:Contract
Start Date / End Date: 05/22/2018 to 06/30/2018
QUALITY MANAGER WITH PHARMACEUTICAL CGMP
PHILLIPSBURG, NJ


Shift: 11:00 p.m. – 7:00 a.m. or 3:00 p.m. - Midnight

Project Description:
Provides Quality Assurance oversight and Product Release functionality for drug products manufactured by the Contract Manufacturer. Primary responsibility is to ensure that Client products manufactured/packaged by Contract Manufacturer are operating in compliance with all Client and applicable FDA and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Client internal and government (FDA or specific market) requirements and support Quality Systems processes.
  • Determines disposition of drug products according to Client and regulatory specifications and standards.
  • Knowledge of packaging tech transfer from internal to external CMO sites.
  • Experienced with serialization for global markets.
  • Provide reviews and approvals for validation/transfer protocols, reports, CV documentation and CV matrix validation strategy per EMA requirements.
  • Review and approve change requests generated internally or Contract Manufacturer.
  • Investigate and/or evaluate manufacturing and laboratory deviations or incidents.
  • Review and approve validation/qualification protocols and reports Contract Manufacturer as defined in related Quality Agreements.
  • Write, review and implement SOPs to ensure compliance with current Client standard and cGMP.
  • Supports product recalls and executes plan as assigned.
  • Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate Client and FDA and EMA agency cGMP regulations and policies.
  • Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant " and Manufacturing Launch teams.

Required Skills:
  • Knowledge in solid dosage forms parenteral technology, biologics or combination products.
  • Knowledge of compendia and cGMP requirements, FDA regulations and the ability to interpret and apply them.
  • Proficiency with the use of global systems (e.g., TrackWise, SAP).
  • Good verbal and written communication skills essential.
  • Excellent interpersonal skills.
  • Capable to manage multiple priorities.
  • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
  • Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.
  • B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy
  • A minimum of 7 years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience.
  • Experience in a Quality Assurance or Quality Control function is required.
  • Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired.

This 1+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00623
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE