Senior Executive Quality Control Job in Zenon
- Kpr sugar apperals
- 4 to 8 Yrs
- Other Gujarat
- 16 days ago
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Job Description
- Key Responsibilities: Quality Control Testing: Supervise and conduct testing on raw materials, in-process materials, and finished products in accordance with pharmacopoeial standards (USP, EP, BP, etc.) and company specifications. Perform analytical testing (e.g., HPLC, GC, FTIR, dissolution testing) to assess the quality of pharmaceutical products. Review and ensure accuracy in test results, and address discrepancies in test outcomes. Documentation & Compliance: Maintain proper documentation for all testing procedures, results, and reports in compliance with Good Laboratory Practices (GLP), GMP, and other regulatory standards. Prepare and review batch records, test reports, and Certificates of Analysis (CoA) for finished products and raw materials. Ensure proper calibration, maintenance, and validation of QC laboratory equipment. Laboratory Management: Supervise day-to-day activities in the QC laboratory, ensuring proper scheduling, resource allocation, and adherence to safety and quality standards. Ensure the lab operates in compliance with GMP, GLP, and health & safety regulations. Mentor and train junior QC staff and lab technicians on testing protocols, equipment use, and quality assurance principles. Deviation and Investigation Management: Investigate any out-of-specification (OOS) results or deviations, determining the root cause and recommending corrective actions. Prepare deviation reports and assist in the implementation of corrective and preventive actions (CAPAs) as needed. Ensure that investigations are thoroughly documented and resolved in a timely manner. Regulatory Audits & Inspections: Assist in the preparation for internal and external audits (e.g., FDA, EMA, regulatory bodies). Provide support during regulatory inspections, ensuring that all documentation and records are readily available for review. Ensure compliance with all relevant regulatory standards (FDA, EMA, ICH, etc.) related to testing and quality control. Quality Improvement: Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of the QC laboratory and testing processes. Recommend and assist in the implementation of improvements in testing methods, systems, and laboratory workflows. Support the development and validation of new analytical methods and testing procedures. Reporting & Communication: Provide regular updates and reports to senior management on the status of quality control activities, including testing results, timelines, and any issues or deviations. Collaborate with other departments (e.g., Manufacturing, R&D, Regulatory Affairs) to ensure alignment on quality control requirements for products. Skills & Qualifications: Education: Bachelors or Masters degree in Pharmacy, Chemistry, Biochemistry, or a related field. Experience: Minimum of 4-6 years of experience in a Quality Control role within the pharmaceutical industry, with at least 2 years in a supervisory capacity. Technical Knowledge: Expertise in various analytical techniques such as HPLC, GC, FTIR, UV-Vis spectroscopy, dissolution testing, and microbiological testing. Familiarity with pharmacopeial standards (USP, EP, BP) and regulatory requirements for quality control. Experience with laboratory equipment calibration and maintenance. Skills: Strong analytical and problem-solving skills. Good communication and interpersonal skills to collaborate with internal and external stakeholders. Ability to prioritize tasks and manage multiple projects effectively. Strong attention to detail and organizational skills. Proficient in using laboratory management software and MS Office applications. Desired Attributes: In-depth understanding of GMP and GLP guidelines. Ability to manage and mentor a team in a fast-paced environment. Knowledge of data integrity principles and best practices. Proactive and solution-oriented with strong decision-making abilities.,
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Not Specified
Functional Area: Not Specified
Role/Responsibilies: Senior Executive Quality Control Job in Zenon
Contact Details:
Company: Zenon HealthcareLocation(s): Other Gujarat
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Keyskills: HPLC GC FTIR dissolution testing analytical techniques regulatory requirements analytical methods development quality control communication interpersonal skills project management UVVis spectroscopy microbiological testing problemsolving
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