QMS Specialist I

Full Time
E Brunswick, NJ 08816
Posted
Job description
Job Summary:

Handling entire Product complaint portfolio - Logging complaints, interacting with Pharmacy/customer, investigation and resolving the complaint and documenting entire investigation
    Assisting in Filing Field Alert Reports
      Handling Vendor qualification program including interacting with compliance team on vendor audits
        Assisting timely preparation of APQRs including communication with the contract giver and Global Regulatory Affairs as needed
          Assisting in managing the established Training programs including annual cGMP Training.
            Review, revise and create standard operating procedures (SOPs) as a part of periodic review and ongoing improvement efforts
              Assisting in external audits (Regulatory / Customer audits) by retrieving and submitting the needed records documents for audit.
                To take part in Internal audits as auditors.
                  To assist in various quality initiatives taken as a part of quality system enhancement.

                  Reporting Relationships

                  • This will be more of individual contributor and will be reporting to Director Quality Assurance.

                  Essential Functions:

                  The person will Log each Market complaint/ Adverse Event received at site. Will interact with the pharmacy/ customer as needed. Will perform investigation and will resolve the complaint. Will make the Investigation report get the needed approval and will close the complaint.
                    ln case if a Field Alert report is to be filed, the person will accumulate all the necessary documents to be submitted along with the filed alert report and will provide to Head QA for filing the Filed Alert report
                      The person will ensure adequate vendor qualification. Will provide all the information of new vendor to Compliance team for Vendor audit and will perform necessary follow-up with Compliance team for Vendor audit and its report. Will gather all the necessary documents related to Vendor qualification.
                        Will prepare APQR as a backup with the concern person handling APQR is not available.
                          As need the person will review and update the existing SOPs, will send the draft SOP to all the related persons for their comments. Will resolve the comments and finalize the SOP. Will take a change control and get the SOP implemented after ensuring training on the updated SOP.
                            Will schedule the routine training and keeping its records updated.
                              During Audits (Customer/ Regulatory), the person will retrieve all the required documents and will provide for inspections as and when needed.
                                Will perform internal audits as per the audit planner.

                                Specialized Skills and Knowledge:

                                Bachelor’s degree with chemistry or pharmaceuticals as major is required at a minimum with 3 plus year of experience.
                                  Knowledge of current cGMP Guidelines as needed for effective function of role
                                    Hands on experience in handling complaints, APQRs, Vendor Qualifications
                                      Knowledge of Statistical techniques

                                      Key Competencies:

                                      1.
                                      Effective Communication (Written and Verbal)
                                      2.
                                      Analytical and Problem-solving ability
                                      3.
                                      Document/ Report drafting

                                      Physical Demands/Factors:

                                      Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.

                                      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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

                                      At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

                                      Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

                                      Avet
                                      is proud to be an Equal Opportunity Employer.

                                      This
                                      job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs .

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