Job Summery: – Ongoing Stability and Laboratory Compliance support has to work in a challenging analytical environment, to ensure the stability requirements for the commercial products and in parallel to ensure the compliance levels within the laboratory.
| Job ID|
|Job Role||QC Officer (Stability)|
|Qualification|| M.Sc (Chemistry)|
|Work Experience||3-5 years|
|Reporting To||Quality Manager|
|CTC||3 LPA- 4 LPA|
It’s a WHO-GMP approved Pharma Company in Bhiwadi (Raj.)
- Execution and management of the Ongoing Stability studies in compliance to regulatory guidelines.
- Management of the Stability chambers in compliance to regulatory guidelines.
- Responsible for preparation of Trend charts of stability testing.
- Liaise with Development R&D teams to understand and interpret data.
- To support analytical investigations for out of specification, out of trend and deviations.
- To ensure the Laboratory practices are in compliance with written procedures and guidelines.
- Designs and performs or coordinates compliance monitoring activities.
- QMS activities in Laboratory are followed correctly and the laboratory is in audit ready state.
- Develops and executes risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups.
- Develops and delivers training in compliance risk areas.
- Work in line with cGMP requirements, global policies and SOPs or any specific requirements.
- Undertake quality activities (as required) such as internal audits in line with a defined schedule.
|Desired Candidate Profile|
- Post Graduate in Chemistry.
- Experience within the healthcare industry is desirable, particularly in a practical / analytical area to GMP standards.
- Experience in HPLC / GC / Dissolution / Wet chemistry / Titrimetry would be an advantage, but not essential.
- Strong presentation and training skills.
- Strong Investigation skills.
- High level of familiarity with broad range of compliance risk areas, in particular relating to regulatory authorities such as USFDA, MHRA etc.
Email Us: firstname.lastname@example.org
Contact: 9218507618 9218507617 9218507616
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