Job Description

Quality Management/Continuous Improvement
Investigation of Deviations
Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc.
Review the Annual Product Quality Review
Batch Reworking/Reprocessing/Reincorporation (Coordination from QA point of view)
Review of Master Batch Manufacturing & Packing Records
Coordination of cGMP training activity including training of the people
Handling of change control system
Document control
Assisting in complaint investigations at site.
Release/ rejection of semi-finished and finished products.
Handling of self inspections
Compliance
Ensure adherence to company Quality Standards, Local FDA and other regulatory authorities
Understanding the requirements
Performing the Gap analysis to find out the gaps in existing system
Preparing a compliance plan for closure of gaps
Execution of compliance plans
Review of completion for compliance activity
Review of the regulatory dossiers, as and when required
Validations & Qualifications:
Preparation & review of Validation Master Plan
Ensure validated status of all equipment manufacturing processes, and cleaning processes
Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning
Review of protocols for qualification and validation of facility/ equipment / product / process
Review and certification of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
Preparation of quality system SOPs
Controlled distribution and archival of documents & record
Control of master documents
Management of archival room
Issuance of batch records, ATR, logbooks and controlled formats.
Assuring quality of products by:
Ensuring SOP compliance
Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
Review of Executed Batch Manufacturing & Packing Records
Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
Ensuring the effectiveness review of the implemented CAPA
Review of batch records & analytical testing records
cGMP Training:
To develop training modules and organize training in GMP
Develop and execute the overall training program in coordination with all concerned departments
QA in QC:
Review of Specifications, protocols, reports and other GMP related QC documents
Review of analytical incidents
Review of OOS investigations and reports
Review of Audit trial for Quality control instruments.
Act as system administrator for Quality control instruments in NIR and Viscometer.
Other:
Implementing the pest control program at Pharmaceutical facility
Review of maintenance and calibration program
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
Dimension (e.g. Budget, number of people managed)
Not Applicable

REQUIREMENTS

Education / Experience
Education:
Graduate / Post Graduate in Pharmacy
Experience:
05-06 years in Pharma industry with awareness of Quality management systems, method validation, Qualification, Regulatory requirements
Behavioral Competencies
(LEAD and others)• Accountability, Authenticity, Collaboration, Courage and Trust