Chemveda Life Sciences is a leading Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) based in Hyderabad, India. We are dedicated to enabling global pharmaceutical, biotechnology, agrochemical, cosmeceutical, academic, and other partners in the life science sector to achieve their R&D goals. With a skilled team of chemists and manufacturing professionals, we provide comprehensive services that help our partners achieve critical milestones faster, more efficiently, and cost-effectively.
Founded in 2008 by Dr. Bheema Rao Paraselli, Chemveda has grown into a powerhouse of over 600 employees with facilities and technology divisions. We have offices in San Diego and Boston in the United States.
Interested candidates can attend walk-in drive or share their profiles to saivardhan.kothuri@chemvedals.com
Note: 3 years service agreement is applicable for freshers
JOB DETAILS:
- Department: QA
- Work Location: Hyderabad
- Experience – Freshers
- Qualification: M.sc(Chemistry) or M.pharm
Job Responsibilities :-
1. Involves in daily QA activities for SOP compliance.
2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments.
3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups.
4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT.
5. Review of Analyst Qualifications and review of Analytical LNBs.
6. Review of Vendor Questionnaires and Review of Vendor qualification documents and checking external facility and vendor audits with respect to raw materials and finished products.
7. Review of new GMP projects with regard to regulatory and client compliance aspects, Scrutiny of GMP facilities and Review of GMP Certifications & all requirements applicable to the projects.
8. Review of SOPs, Specifications, Method of Analysis and Analytical test data sheet.
9. Review of Method transfer protocols and reports, Validation protocols and reports, Forced degradation data and Review of quality impacting incidents, OOS and Data corrections.
10. Lab rounds and Compliance verification and Qualification of GMP Contract Manufacturing Facilities (CMO).
a. Circulation of Non-compliances
b. Circulation of Non-Compliance reports to CMO
11. Circulating agenda for Internal Audits and Management review meetings, Reporting & Circulation of Non-Compliances and Suggestion of appropriate CAPAs.
12. Functional Objectives: Follow-up & review of the objectives action plan and Data collection & compilation.
13. Review of weekly and monthly reports and collecting data.
14. Monitoring of QMS activities as per ISO & Client requirements.
15. Document issuance, retrieval and archival, document control.
16. During the audits, to coordinate with the with the auditors to show and explain the documentation of quality systems & procedures.
17. Preparation quality system procedures and quality manual.
18. To prepare audit compliance reports or responses and to ensuring the successful closure of audit cycle.
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