Job Description

Full Job Profile :- Quality Control Executive (QC) Documentation
Job Location :- Roorkee
Qualification :- Bsc /Msc/ B.Pharm/ B.tech/Pharma Exp:- 2yr -3yr ( Pharma Division)( (Tablet, Capsule, Liquids, Suspension, and Parental etc.). JOB RESPONSIBILITIES To strength and maintain the quality system in QC Laboratory as per regulatory requirements. \xe2\x9d\x96 To plan the sample analysis to analyst & ensure the issuance of laboratory worksheet on daily basis as to get maximum output from the team. \xe2\x9d\x96 Troubleshooting of sophisticated analytical instrument. \xe2\x9d\x96To review the Analytical and Calibration data along with soft copy and audit trial on Empower software. \xe2\x9d\x96 To prepare and review of specification, STP, SOP, GTP, analytical record and COA. \xe2\x9d\x96 To review of Analyst Qualification data. \xe2\x9d\x96 To verify online activity performed in QC Lab. \xe2\x9d\x96 To ensure qualification documents of QC instrument and Equipment\xe2\x80\x99s. \xe2\x9d\x96 To conduct cGMP, cGLP training program. \xe2\x9d\x96 Preparation & review of stability study protocol, stability compilation sheet & stability planner. \xe2\x9d\x96 GLP Activity (Procurement and Maintenance of reference standard, Impurity standard, Chemical) \xe2\x9d\x96 Accountable for ensuring non-conforming material investigation through OOS, OOT, handling of incidents and decisive role for corrective and preventive action (CAPA) as per laid down procedure. \xe2\x9d\x96 To ensure compliance for various GMP/GLP monitoring tools like internal quality audits. \xe2\x9d\x96Responsible for performing gap assessment as per GMP guideline for continual improvement of Quality management system and perform remedial action for identified gap & associated risk with Appropriate mitigation plan. \xe2\x9d\x96 21 CFR, par 11, EU Annexure 11 compliance verification. \xe2\x9d\x96 Audit trial verification and electronic data review. \xe2\x9d\x96 Monitor and implementation of all pharmacopeia changes as per IP/BP/USP/EP/JP. Knowledge of Finished and Stability sample Analysis (Tablet, Capsule, Liquids, Suspension, and Parental etc.). \xe2\x9d\x96 Knowledge of Working Standard Preparation. \xe2\x9d\x96Knowledge of LIMS(Labware-7) 1. Protocol approval which is prepared by TSD. 2. Creation of master data in LIMS. 3. Dynamic protocol preparation and review (stability sample loading & unloading). 4. Test article, Products & Analysis. 5. Sample receiving from chamber to Lab & Work allocation. 6. Review of analytical Results. 7. Review of results & print \xe2\x9d\x96Knowledge of EDMS. 1. Preparation and review of Specification, SOP, STP & Miscellaneous protocol. \xe2\x9d\x96 Knowledge of Track wise. 1. Initiator of OOS/OOT/Deviation in Track wise. 2. Review of investigation in Track wise. Contact Person: Sphurti srivastava ( HR) sphurti@lucentbiotech.com 9532877108 Job Types: Full-time, Regular / Permanent Salary: 915,000.00 - 920,000.00 per month Benefits:

• Health insurance
• Life insurance
• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Overtime pay

Ability to commute/relocate:

• Lucknow, Uttar Pradesh: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 4 years (Preferred)

Speak with the employer
+91 9532877108