.
Ensure issuance, revision, retrieval, and archival of controlled documents.
Maintain real-time and accurate GMP documentation.
3. ERP Pharma Software - Data Entry & Documentation
(Mandatory Skill)
Perform QA approvals, document controls, batch record checks in ERP.
Manage
material status, QC release, batch disposition, change controls
via ERP.
Maintain audit trails and data integrity using ERP modules.
Ensure electronic document management and updated QA records.
4. Shop-Floor Quality Assurance
Perform
line clearance
for production and packaging areas.
Monitor compliance with GMP practices across all shifts.
Oversight of sampling procedures for RM, intermediates & finished APIs.
5. Regulatory & Customer Audit Support
Support audits from
FDA, EDQM, WHO, TGA, MHRA, and customer audits
.
Prepare audit documents, responses, and implement corrective actions.
Ensure audit readiness for internal and external inspections.
6. Validation & Qualification Support
Review or approve validation protocols & reports:
Process Validation
Cleaning Validation
Equipment Qualification
Ensure compliance with quality and regulatory expectations.
7. Investigations & RCA
Conduct or support investigations for:
Deviations
OOS / OOT
Complaints
Failures
Use tools such as
5-Why, Fishbone Analysis, FMEA, QRM
.
8. Training & Quality Culture
Conduct training on
GMP, GDP, documentation, data integrity
.
Promote "Right First Time" and continuous improvement in QA practices.
Required SkillsTechnical Skills
Strong knowledge of
API GMP, QMS, ICH Q7, data integrity
.
Expertise in batch documentation review & controlled document management.
Hands-on experience with
QMS activities (Deviation, CAPA, OOS, OOT)
.
Solid ERP software usage capability in QA workflows.
Basic understanding of analytical chemistry (HPLC/GC experience preferred).
Soft Skills
Excellent communication & audit-handling ability.
Strong documentation discipline and attention to detail.
Effective coordination with Production, QC, Warehouse & R&D.
Leadership qualities for senior-level role.
Experience Required
Minimum 7-10+ years
in
Quality Assurance of API manufacturing plant
.
Must have experience in QMS, batch review, controlled documents, QA shop-floor.
ERP pharma software experience is mandatory.
Regulatory audit exposure preferred for Sr. QA Officer role.
Salary Range
?3,00,000 - ?7,00,000 per annum
, depending on:
Skill-set
Audit handling experience
ERP proficiency
Level (Officer vs Sr. Officer)
Previous CTC
Benefits may include: