Team Member – QA Validation

Qvents.In; Amaravati; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Dr.Reddy's Laboratories in Andhra Pradesh seeks a Team Member in Quality Assurance, focused on facility and equipment qualification, VMP compliance, and audit trails. The role involves reviewing qualification protocols, reports, and calibration records, and participating in investigations related to deviations.

The candidate will ensure compliance with GMP, assist in SOP preparation, and handle documentation across DocHub, e-VAL, and SAP DocuSign systems as applicable.

Qualifications

• 5–10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance.
• Experience in Validations, Qualifications of Systems, Processes, Sterile Assurance

Responsibilities

• Review of qualification protocols and reports for facility, area, equipment, and utilities.
• Review and approval of smoke study protocol and report.
• Review of VMP and their revisions; ensure requalification calendar compliance.
• Review of GMP documentation, audit trails, calibration certificates, and maintenance plans.
• Participate in investigations triggered by incidents or deviations.
• Prepare and review SOPs as required.
• Review of documents in DocHub, e-VAL, and SAP DocuSign for compliance.
• Gemba walks in utility systems and review of validation reports.

Skills

Investigations

Quality Assurance

Validations

Sterile Process Validation

Facilities Qualification

Education

Bachelor or Master in Pharmacy

Tools

DocHub

e-VAL

SAP DocuSign

Job description

Designation : Team Member

Function : Quality Assurance

Functional Area : QA Validation

Job Role Summary : Facility and Equipment Qualification – Review of Protocols and Reports, VMP Compliance, Review of Audit Trials, Sterile Process Validations

Job Profile

• Review of qualification protocols and reports of facility, area, equipment, and utilities including URS, DQ/FS, RA, SLIA, Project specific qualification plan, commissioning checklist, IQ, OQ, UTM, PQ & RQ.
• Review and approval of smoke study protocol & report.
• Review of VMP and their subsequent revisions.
• Review of VMP re-qualification calendar for all equipment, facility, Utility etc.
• Review of PMP check list/schedules and Master calibration and Facility maintenance planner etc.
• Review of Audit trails, master instruments calibration certificates.
• Review of logbooks for its compliance and good documentation practices.
• Ensuring compliance to VMP revalidation schedule as per revalidation matrix for all equipment, facility, utility etc.
• Allotment of numbering for equipment’s, area, layouts and to prepare / Update the List.
• Handling and closure of quality management system which includes change controls, incidents & CAPA.
• Participation in investigations that are triggered due to incidents/deviations as applicable.
• Responsible for preparation, review of SOP as per requirement.
• Review of BMS & EMS related documents and alarms & audit trials reports for its compliance.
• Review of activity related to critical equipment breakdown notification.
• Review of equipment breakdown and general maintenance notification.
• Compilation and Preparation of Annual review of utilities reports.
• To perform GEMBA walk in utility system i.e. HVAC, compressed air, and water system, etc.
• Review of Pure steam quality reports, compressed air and nitrogen gas testing reports.
• Review of documents in DocHub, e-VAL, SAP DocuSign as applicable.
• Review of cleaning validation protocols and reports.

Job Requirements

• 5 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance
• Experience in Validations, Qualifications of Systems, Processes, Sterity Assurance

Work / Job Experience : 5-10 Years

Type of Experience : Pharma QA, Sterile Process Validation, Facilities Qualification

Academic Qualifications

• A Bachelor's or Master's degree in Pharmacy,

Job Post Link : https://tinyurl.com/23cwjefe

• Full Time
• India | Andhra Pradesh | Pydibimavaram

Website Linkedin Dr.Reddys Laboratories