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Quality Control Executive

3 weeks ago

Roorkee, India Lucent Biotech Ltd. Full time

**Full Job Description**

**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.

❖ To plan the sample analysis to analyst & ensure the issuance of laboratory worksheet on daily basis as to get maximum output from the team.

❖ Troubleshooting of sophisticated analytical instrument.

❖To review the Analytical and Calibration data along with soft copy and audit trial on Empower software.

❖ To prepare and review of specification, STP, SOP, GTP, analytical record and COA.

❖ To review of Analyst Qualification data.

❖ To verify online activity performed in QC Lab.

❖ To ensure qualification documents of QC instrument and Equipment’s.

❖ To conduct cGMP, cGLP training program.

❖ Preparation & review of stability study protocol, stability compilation sheet & stability planner.

❖ GLP Activity (Procurement and Maintenance of reference standard, Impurity standard, Chemical)

❖ 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.

❖ To ensure compliance for various GMP/GLP monitoring tools like internal quality audits.

❖Responsible 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.

❖ 21 CFR, par 11, EU Annexure 11 compliance verification.

❖ Audit trial verification and electronic data review.

❖ 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.).

❖ Knowledge of Working Standard Preparation.

❖Knowledge 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

❖Knowledge of EDMS. 1. Preparation and review of Specification, SOP, STP & Miscellaneous protocol.

❖ Knowledge of Track wise. 1. Initiator of OOS/OOT/Deviation in Track wise. 2. Review of investigation in Track wise.

9532877108

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹15,000.00 - ₹20,000.00 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