23 Oct
|
Globela Pharma
|
India
23 Oct
Globela Pharma
India
Location: Sachin, Surat, Gujarat
Experience: 2–3 Years
Job Type: Full time
Department: Quality Assurance (QA)
Industry: Pharmaceutical Manufacturing
Job Summary
We are looking for an experienced and detail-oriented QA Documentation Executive with 2–3 years of experience in the pharmaceutical industry. The candidate will be responsible for packaging artwork verification, ERP and Pharma Cloud operations, batch management, SOP control, quality documentation, and compliance-related activities.
Key Responsibilities
1. Artwork & Packaging Material Management
- Review, verify, and approve packaging artworks.
- Check batch numbers on preprinted artworks.
- Generate packaging material codes in the ERP system.
- Upload approved artworks into Pharma Cloud.
- Verify packaging material and batch details with the QC department.
- Monitor the disposal of rejected packaging materials and maintain records.
2. ERP & Pharma Cloud Operations
- Add and verify master formulas for RM/PM.
- Create and maintain generic, raw material, packaging material, and other material masters.
- Perform batch creation and procurement planning in the ERP system.
- Upload SOPs into Pharma Cloud.
- Initiate QMS activities in Pharma Cloud 360.
- Perform batch creation, packed product release, and reclassification in Pharma Cloud.
- Generate batch numbers and maintain batch manufacturing issuance and receipt registers.
3. Quality Documentation & Compliance
- Prepare Annual Product Quality Review (APQR) reports.
- Review and issue SOPs.
- Manage controlled documents, including SOPs, BMR/BPR, protocols, formats, and logbooks.
- Handle document preparation, review, distribution, retrieval, revision, storage, retention, and destruction.
- Review completed BMR/BPR documents and attach relevant COAs.
- Cross-verify batch details in BMR/BPR.
- Assist in audit preparation and maintain proper documentation records.
4. Batch & Production Coordination
- Allocate and cross-check product batch numbers against sales orders.
- Verify stereo details as per issued BMR/BPR and coordinate issuance to the packing department.
- Check party samples and arrange dispatch as required.
- Coordinate stability sample charging and withdrawal, along with samples submitted to QC and Microbiology.
- Ensure all relevant sample entries are updated in Pharma Cloud.
Required Qualifications & Skills
- Graduate in Pharmacy, Chemistry, or a related discipline.
- 2–3 years of relevant experience in the pharmaceutical industry.
- Practical knowledge of QA documentation, packaging artwork, ERP systems, and Pharma Cloud.
- Knowledge of SOPs, BMR/BPR, APQR, QMS, and batch documentation.
- Strong attention to detail, documentation skills, and coordination abilities.
Work Location: Sachin, Surat, Gujarat
Interested candidates are requested to apply through Indeed with their updated resume.
Pay: ₹240,000.00 - ₹400,000.00 per year
Benefits:
- Provident Fund
Work Location: In person
📌 QA Documentation Executive – ERP & Packaging Artwork (India)
🏢 Globela Pharma
📍 India