- Determine whether quality activities and related results comply with cGMP requirements.
- Ensure that all master documents impacting the identity, strength, quality and purity of the drug product are reviewed and approved by the QA unit before use or subsequent change.
- Ensure proper disposition (Approval / Rejection) of all raw materials, packaging materials, in-process and finished products.
- Ensure that all the deviations, out of specifications are adequately investigated and appropriate corrective and preventive actions are taken.
- Ensure that all the changes to the existing documents, systems, equipment are properly documented, accessed, approved and tracked.
- Ensure a proper system for managing stability studies of new products as well as ongoing products.
- Ensuring completion of all yearly trend analysis in time.
- Ensure that all the customer complaints are adequately investigated and appropriately resolved including any corrective and preventive actions.
- Imparting various quality training including annual cGMP Training.
- Ensure that all the quality documents are archived, retained and destructed in a timely manner as a part of management of document control functions.
- Ensuring all time readiness for any external audits (Regulatory / customer audits)
- Ensure participation and support in various site initiatives for quality and productivity.
- Timely provide the quality documents for any new products / changes to RA for filing purpose to agency.
- Actively participate in Internal Audit program. If required act as a Lead Auditor.
- Serves as a back to Head QA, in his/her absence.
- QA sections namely QMS, Stability and Document control will be reporting to Associate Director (QA).
- This position will report to Head QA.
- Day to day tracking of shipments as a basis of schedule attainment
- Review and release of certificate of Analysis
- Review and approve all the Lab deviation reports, Out of specification reports and manufacturing deviation report as needed
- Review of customer complaints
- To manage entire Management review process, right from data collection, preparation of presentation and to conduct the management review meetings.
- To review and provide all the QA related documents to RA for filing of CBE-30 / PAS.
- To compile yearly deviation trend report.
- To review other trend analysis report (Temperature/humidity, water system, Environment monitoring, Out of specifications)
- Serve as key auditee during customer audits and serve as key contact person for customer audit related communication, including preparation of action plant report against the audit observation and closure of the report
- Over see the working of document control, APQR preparation, Vendor qualification and Stability control area and to trouble shoot / guide the document control persons as needed.
- 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.
Specialized Skills and Knowledge:
- Bachelor or Master’s degree in Science with Chemistry as Major or Pharmaceutical Science
- Minimum 7 – 10 years of Experience of QA in a pharma Company
- Knowledge of current cGMP Guidelines
- Knowledge Basic analytical functions of Pharma Industry (HPLC, GC, UV etc )
- Communication (Written and Verbal)
- Problem solving ability
- Presentation skills
- Document / Report drafting
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.
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