Quality Control(FDA Approved Chemist)
- Jalaram Enterprise
- 3 to 7 Yrs
- Navsari, Vapi, Valsad
- 6 years ago
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Job Description
Overall responsibility of administrative and technical functions of quality control department
Selection & training of new employee
Selection and Procurement of Laboratory instruments.
New equipment qualification & approval of IQ/OQ/PQ
Responsible to monitor the completion of day-to-day analytical work and planning.
Responsible for timely release of Raw Materials, Packaging Materials, In-processResults, Intermediates andFinished Products.
Responsible for the laboratory compliance and develop good laboratory practices.
Involve in Internal Audits as well as external audits and its compliance.
Ensure stability Calendar & Stability Analysis Schedule.
Impart training to personnel (Induction, SOP, GLP, etc.) to improve operational efficiency and for the continual development of QC Personnel and to ensure GLP & safety standards in the laboratory.
Reporting deviation and Change control.
New chemist validation & define job responsibility.
Approved Protocol for analytical validation & cleaning validation.
Check and approved Specification, standard test procedure, protocols & analytical work sheet of RM/PM/FG/Stability.
To ensure quality control specifications and analytical methods are confirming to the latest Pharmacopoeia & customer requirements.
Deviation, change control & customer complaint are investigated, addressed and closed accordingly with necessary corrective & preventive action.
Approve Laboratory Trend Data.
To review and approved analytical reports, COAs.
To Co-ordinate with outside agencies as and when required.
To Ensure backup of instruments whenever required taken at required time
At time readiness for any regulatory audit
Handling deviations, change control, OOS.
To ensure safety precaution in laboratory.
To ensure the implementation of GLP system and CFR part 11 compliance in laboratory.
Employement Category:
Employement Type: Full timeIndustry: Pharma / BiotechRole Category: Quality (QA-QC)Functional Area: Not ApplicableRole/Responsibilies: Quality Control(FDA Approved Chemist)Contact Details:
Company: Jalaram EnterpriseLocation(s): Navsari, Vapi, Valsad
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