Quality Control Executive

• A minimum of 4-5 years related experience in QC pharmaceutical manufacturing company.

Job Profile

A Quality Control Officer is a professional who is Responsible for the Raw materials. in process and finished product and also stabling samples analysis and had knowledge of handling instruments like HPLC , UV-visible spectrophotometer , Dissolution Apparatus, pH meter , viscometer , KF, Polarimeter , Refractometer, Friabilator, D.T. Apparatus etc.

Roles & Responsibilities:

Responsible for in-process and finished product analysis and also analysis of stability samples. Handling instrument like HPLC, UV-visible spectrophotometer, Dissolution Apparatus, pH meter, viscometer, KF, Polarimeter, Refractometer, Friabilator, D.T. Apparatus etc.

• Analysis of finished product, stability product and raw material.
• Preparation of SOP for related to instrument and system.
• Preparation of protocol, worksheet for raw material and finish product.
• Documentation like ATP, Development report, Validation protocol, Validation report, STP preparation.
• Performing sample based check, monitor transactions & provide feedback on quality.
• Sampling of Raw material, entry, packaging and labeling.
• Supporting completion of audit checklist in advance for all internal/ external audits.
• Assisting company s external auditors for preparation of documentation for control weakness/ error remediation.
• Standardisation and Calibration of Instruments.
• Water analysis.
• Perform other duties as assigned.

Candidate Profile / Skill required

• Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
• Working knowledge of Analytical Method development and validation.
• Working knowledge of process, Reflux process, Carbon treatment, Purification process, Addition process and Separation process.
• Handling of instruments like HPLC/Spectrophotometer etc.
• In-depth understanding of company standards
• Up-to-date knowledge of federal and industry standards and best practices
• Basic computer and math skills to calibrate and measure specifications
• A keen eye for detail
• Good verbal and written Communication skills