27 Arco Lab Jobs
2-7 years
₹ 3.5 - 8.5L/yr
Bangalore / Bengaluru
1 vacancy
Executive - Packaging Develpoment (Injectables) - Steriscience
Arco Lab
posted 17hr ago
Flexible timing
Key skills for the job
Dear Candidate,
We currently have an opening for the position of Executive - Packaging Development (Injectables). If you have experience in sterile injectables, parenteral, vaccines, or Ophthalmics and are eager to make an impact, we want to hear from you.
Company: Steriscience Specialties Pvt Ltd
Website: www.steri-science.com
Work Location: Bilekhalli (Opposite to IIM), Bannerghatta Road, Bangalore
Qualification: B. Pharm/M. Pharm
Experience: 2 - 7 years (experience should be in sterile Injectables/ Parenteral/ Vaccine/ Opthalmic)
Background of job: Working experience in regulated markets (sterile Injectable/ Parenteral/ Opthalmic/ Vaccine)
Department: Packaging Development
Designation: Executive
Key Responsibilities
1. Preparation Design control Documents URS, DI, DO, DV, DR, DHF as per 21CFR 820.30 and EU MDR
2. Verification of design control data
3. Preparation of graduation development protocol for prefilled syringe label
4. Verification and validation graduation labels.
5. RLD characterization on need basis
6. Sample arrangement for testing activity & development activity
7. Ensure document approvals from respective CFTs
8. Responsible for timely submission and to addressing regulatory deficiencies in co-ordination with cross functional teams.
9. Cost improvement proposal for packaging components.
10. Ensure the compliance to the laid down systems and procedures with respect to Quality and regulatory requirements.
11. Responsible for the Preparation, & Review of SOPs and relevant training activities & records.
12. Ensure to follow Good Documentation practices, Quality Management systems such as Change Control, deviations for continuous compliance.
13. Responsible for design and development of Primary, secondary and Tertiary packaging components
14. Preparation of Master packaging record , BOM, Calculations and instructions
15. Responsible to provide to description details for item code creation to create in SAP in coordination with CFT members.
16. To provide Master data inputs for Serialization as per respective guidelines.
17. Coordinating for the Blister change part development and arranging samples for machine feasibility trials
18. Coordinating with vendors to get the supporting documents and drawing approvals.
19. Review of Artworks Print proofs and shade cards of all components developed across site.
20. Design and development activities for all products with respect to tech transfer and site variation projects.
21. Preparation of Specification and STP
22. Coordinate with QA, QC and other departments with respect to Specifications and Test methods finalisation.
23. CAPA and Change control activities and Timely closure of Track Wise deviations, CAPA's and Task.
Interested candidates can share their resumes to Pooja.Thakkar@arcolab.com with subject line Resume - Packaging Development - Injectables
Employment Type: Full Time, Permanent
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