Nesher Pharmaceuticals (USA) LLC
  • 07-Sep-2017 to 06-Oct-2017 (CST)
  • Quality Assurance
  • Pennington, NJ, USA
  • Full Time

Competitive Benefits Package


Zydus Pharmaceuticals (USA) Inc. is located in Pennington, NJ, and is the U.S. division of Cadila Healthcare. Since our first commercial launch in August of 2005, we have grown steadily and are now one of the top 10 U.S. generic companies in total prescriptions dispensed. We are also proud to note that since 2005 we have been recognized annually by IMS Health as one of the fastest growing pharmaceutical companies in the U.S. Zydus is focused on providing outstanding customer service, along with high-quality, affordable generic products to our customers and their patients.

Job Summary:

Support manufacturing activities at Contract Manufacturing Organizations (CMOs) by providing quality oversight. Accomplishes quality objectives by planning and evaluating project activities. Essential duties and responsibilities include, but are not limited to, the following: This will include qualification, day-to-day operational activities, audit reporting, exiting/transferring activities.

Essential Job Functions:

  • Qualify, manage, support and supervise assigned CMO sites aligned with the Zydus Pharmaceuticals USA Inc. Quality Management Systems.
  • Responsible for creation of Quality Assurance Agreements and maintain according to Zydus Pharmaceuticals USA Inc.'s requirements, ensuring that Quality agreements are regularly reviewed and followed at CMO sites.
  • Execute, implement and maintain a Quality Systems of Zydus Pharmaceuticals at assigned CMO sites as appropriate.
  • Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product CMOs.
  • Ensure timely review and approval of all master Manufacturing records (MRs)Packaging records, change controls, Standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related commercial drug product manufacturing at contractors and/or business partners.
  • Ensuring timely release of the finished product by reviewing the COA and temperature data loggers.
  • Manage (initiate and investigate) all significant quality issues associated with Drug Products originating from assigned CMOs (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
  • Provide support for readiness regulatory agency inspections and requests, interacts directly with CMOs to resolve quality issues.
  • Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
  • Perform regular Contract Manufacturer Oversight activities including product and site audits.
  • Assure Corrective Actions are developed and executed in a timely manner by assigned Contract Manufacturers.
  • Perform/Support Vendor Qualification of all Raw materials, Packing materials of CMOs.
  • Perform other duties as assigned.

Requirements and Qualifications:

  • Strong understanding of regulatory requirements for commercial products.
  • Broad knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
  • Strong technical understanding of pharmaceutical processes.
  • Strong cGMP experience and knowledge, QA/QC, and regulatory compliance (US, EU and other international agencies).
  • Quality Product release experience is an asset.
  • Strong interpersonal skills, excellent communication and presentation skills, strong negotiation and influencing skills.
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
  • Team player, task oriented and skilled in functioning in a cross-cultural working environment
  • Ability to effectively manage multiple complex and competing priorities Strong reporting skills.

Education or Equivalent:

  • Requires BS/BA in a scientific discipline with 7-10 years of related experience in a cGMP environment, for pharmaceutical industry.

Experience:

  • Minimum of 7 years of experience in manufacturing of pharmaceuticals drug product.
  • Minimum of 7 years of Quality Assurance/Quality Control experience is required.
  • Operational knowledge of aseptic processing and packaging operations is a plus.
  • Experience managing and auditing CMO is Preferable.
  • Certification from ASQ-CQA is preferable.

Physical Requirements:

  • Must have the ability to travel both internationally and domestically as required for this role, approximately 60%Must have English language fluency, both written and verbal. Any other language is a plus. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is regularly required to stand, walk, sit, stoop, and bend.
  • Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
  • Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
  • Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

 

Nesher Pharmaceuticals (USA) LLC
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