Job description
Cosette Pharmaceuticals is a US based, diversified pharmaceutical company with a proven topicals and dermatology portfolio and a growing branded pharmaceuticals business. We are fully integrated, with a deep focus on internal R&D, high quality manufacturing standards and commercial sales excellence. We continue to diversify and expand through strategic partnerships, acquisitions and internal R&D.
Our highly experienced leadership team are busy writing the next, most ambitious chapter of our story. Building on a 100+ year heritage, their shared vision of innovation will leverage the expertise of more than 350+ team members, and infrastructure to create remarkable new opportunities for the patients and physicians we serve every day.
Cosette is headquartered in Bridgewater, NJ with 2 additional locations in the U.S. The South Plainfield, NJ office consists of an R&D Laboratory and other functional areas. The Lincolnton, NC site is a fully functioning, state of the art, manufacturing facility.
Innovating every day.™
The Quality Affairs Specialist performs various activities that ensure and support the regulatory compliance of the operation.
Essential Functions and Responsibilities:
- Oversee the Cosette Complaint Intake and Closure process by interfacing with customers on complaints. Responsible for ensuring timely recognition of critical complaints, adverse events, and communication to Quality Management and Pharmacovigilance. Perform Complaint Investigations into customer complaints by reviewing documentation, examining retain samples, and working with internal departments to arrive at the root cause and recommend appropriate CAPA; perform trending analysis; and respond to the complainants, as required.
- Annual Product Review generation: Prepare Annual Product Reviews according to the scheduled due dates. Perform Statistical Analysis, identify and evaluate product trends, and recommend CAPAs to management as required.
- Participate in Internal Audits to assess compliance to GMPs.
- Participate in Regulatory Field Actions: Participate in Field Actions such Recalls, Field Alerts, etc. as required.
- Other Duties as assigned by Manager.
Knowledge, Skills, Qualifications and Physical Requirements:
Education/Training/Work Experience:
- BA/BS in Chemistry/Biology/related science or Comparable Post Secondary Schooling with applicable industry experience
- At least 5 years industry experience with knowledge of Pharmaceutical Systems.
Specialized Knowledge and Skills:
- Strong problem solving and investigative skills
- Excellent oral and written communicative skills
- Understanding of Regulatory Codes
- Good interpersonal skills
- Computer Literacy
Equipment and Applications:
- Microsoft Software
- TrackWise Software
- SAS® Software
Work Environment and Physical Demands:
- Ability to occasionally lift up to 50 pounds
- Ability to withstand short periods at elevated temperatures (hot/cold)
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