Qc Executive

6 months ago

Dehradun Uttarakhand, India Sanidhya Sansar Ventures Full time

Job Title: QC Executive (Analytics Method Validation)

**Responsibilities**:
1. Develop and validate analytical methods for quality control (QC) testing of pharmaceutical products.

2. Design and execute experiments to validate analytical methods following regulatory guidelines (e.g., ICH, FDA, EMA).

3. Perform statistical analysis of validation data to ensure method robustness, accuracy, precision, specificity, and linearity.

4. Prepare validation protocols, reports, and documentation in compliance with regulatory requirements.

5. Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure timely method validation and implementation.

6. Troubleshoot analytical method issues and provide technical support to QC analysts.

7. Stay abreast of industry trends, technological advancements, and regulatory changes related to analytical method validation.

8. Participate in internal and external audits, providing expertise on analytical method validation processes.

9. Contribute to continuous improvement initiatives to enhance QC processes and efficiency.

10. Train QC personnel on validated analytical methods and relevant procedures.

**Requirements**:
1. Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or related field.

2. Proven experience (3-5 year) in analytical method validation within the pharmaceutical industry.

3. Strong understanding of regulatory guidelines and requirements for analytical method validation.

4. Proficiency in statistical analysis software (e.g., JMP, Minitab) and analytical instrumentation (e.g., HPLC, GC, UV-Vis).

5. Excellent communication and teamwork skills, with the ability to collaborate effectively across departments.

6. Detail-oriented mindset with strong problem-solving abilities.

7. Ability to work independently and manage multiple projects simultaneously.

8. Familiarity with quality management systems (e.g., cGMP, GLP) is preferred.

9. Certification in relevant areas (e.g., Six Sigma, Lean) is a plus.

10. Commitment to maintaining high standards of quality, safety, and compliance in all activities.

Pay: ₹22,000.00 - ₹30,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Performance bonus

**Experience**:

- total work: 3 years (preferred)

Work Location: In person

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