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Quality Assurance Officer (QMS)

3 - 6 YearsPanjim

Posted: 18 days ago

Job Description

To verify and certify line clearance of critical operations.
To check online records.
To check critical steps of manufacturing and packing operation and to carry out in process checks.
To ensure all instruments are calibrated and validations are carried out in timely manner.
To withdraw samples for analysis at intermediate and finished product stage.
To monitor steps followed in manufacturing and packing are as per standard operating procedure.
To carry out sampling of process validation samples/ cleaning validation swab and rinse samples.
To review and compile complete batch records (BMR and BPR) prior to release.
To identify and report the non-compliances observed in individual departments.
To withdraw Stability & Reference Samples.
To issue BMR/ BPR as per the Production Plan.
To issue Process Validation, Cleaning Validation Protocols etc.
Issuance of additional BMR & BPR pages.
To issue Process Validation, Cleaning Validation Protocols etc.
Handling of Password Policy.
To review & maintain Corporate & Site Change Control & their respective logs.
Handling of Artwork / Proof / Shade Cards. & Master Specimen
To issue Monthly logs of all Departments.
Management of Master Copies like BMR & BPR.
BMR review (Apart from IPQA)
To prepare Annual Product Quality Review.
Vendor Assessment of Raw Material & Packing Material.
Handling of Stability Studies, Stability Protocol preparation and to review Stability Summary Report.
Batch release and Dispatch.
To issue controlled copies and retrieval of old SOPs and QAPs. (SOP / QAP Management).
Any other assignments allocated by Unit QA.

Salary: INR 3,00,000 - 4,75,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Employment Type: Permanent Job, Full Time
Keyskills:

Desired Candidate Profile


Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required

Company Profile

FDC Limited
his campus has multi product Tablet and Capsule manufacturing facilities.

It has a State-of-the-Art Pilot plant for manufacturing Exhibit batches for Regulated Markets. This facility has been successfully inspected by UKMHRA, W.H.O, NDA-Uganda & PPB- Kenya. The products manufactured are exported to Europe, CIS, Asia-Pacific and African countries.
View Contact Details+
Contact Details

Recruiter Name:Jagdish Vasta

Contact Company:FDC Limited

Reference Id:QMS 001