Assistant Manager - Quality Assurance (Engineer)
- Cdymax India Pharma
- 10 - 14 years
- Bengaluru
- 2 months ago
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Job Description
Job Responsibility :
- Complaints Engineering:
- Investigate and resolve quality complaints related to API products.
- Implement corrective and preventive actions (CAPA) to address root causes.
- Maintain detailed records of complaint investigations and resolutions.
- Calibration:
- Oversee the calibration of production equipment and instruments to ensure accurate measurements.
- Coordinate with external agencies for calibration services.
- Review and approve calibration reports and ensure compliance with industry standards.
- Qualification:
- Develop and execute Equipment Qualification (EQ) protocols and reports.
- Ensure that all equipment meets operational and safety standards before use.
- Maintain qualification documentation and ensure traceability.
- Validation:
- Prepare and execute Process Validation (PV) protocols and reports.
- Ensure that manufacturing processes consistently produce products meeting quality standards.
- Collaborate with cross-functional teams to implement validation strategies.
- SOP Preparation:
- Develop, review, and update Standard Operating Procedures (SOPs) for manufacturing processes.
- Ensure SOPs are aligned with regulatory requirements and industry best practices.
- Train staff on SOPs and ensure proper documentation practices.
Qualifications:
- Bachelor's degree in Engineering Background Candidate can apply.
- 1012 years of experience in Quality Assurance within the pharmaceutical API industry.
- Strong knowledge of calibration, qualification, and validation processes.
- Experience in preparing and reviewing SOPs.
- Familiarity with regulatory requirements and industry standards.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
Preferred Qualifications:
- Certification in Quality Management Systems (e.g., ISO 9001, GMP).
- Experience with Lean Six Sigma methodologies.
- Knowledge of statistical analysis and process control tools.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Cdymax India PharmaLocation(s): Bengaluru+ View Contact
Keyskills: Test Engineering Qualification Testing Validation Testing Quality Assurance Engineering Calibration Testing Software Testing Sop Preparation
Fraud Alert to job seekers!
₹ -9 Lacs P.A
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Cdymax India Pharma
Cdymax (India) Pharma Private Limited was founded in 1994. The company's line of business includes the manufacturing, fabricating, or processing of drugs in pharmaceutical preparations for human or veterinary use.
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