Quality Control Hplc Operator Pharma
2 months ago
**Job description**
**Full Job Description**
**Job Profile:
- Quality Control Executive (QC)**
**Job Location:
- Roorkee**
**Qualification:
- Bsc /Msc/ B.Pharm/ B.tech/Pharma**
**Exp:
- 2yr -5yr ( Pharma Division)(** (Tablet, Capsule, Liquids, Suspension, and Parental etc.).
**JOB RESPONSIBILITIES**
- **Analysis of raw materials.**
- **Analysis of working standard**
- **Analysis of F.N product's maintain of documents & STP; STS, protocol preparation**
- **Maintain The log book Records.**
- **Prepration the STP STS of Raw material and finesh product.**
- **Preparation of U.R.S**
- **Analysis of Row water, purified water, water for injection ,PSG water.**
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.
**Salary**: ₹20,000.00 - ₹25,000.00 per month
Contact Person: Sphurti srivastava ( HR)
9532877108
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹20,000.00 - ₹25,000.00 per month
**Benefits**:
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Haridwar, Uttarakhand: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 5 years (preferred)
**Speak with the employer**
+91 9532877108
- Health insurance
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