Senior Executive/assistant Manager Ar&d
Year Anakapalle, Andhra Pradesh, India
Job Description
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Position: Sr. Executive/Assistant Manager - AR&D
Company: API Buk Drug Pharmaceuticals
Location: Parawada, India Roles and Responsibilities:
+91 8125394001
Position: Sr. Executive/Assistant Manager - AR&D
Company: API Buk Drug Pharmaceuticals
Location: Parawada, India Roles and Responsibilities:
- Method Development and Validation: Lead and participate in the development and validation of analytical methods for the analysis of active pharmaceutical ingredients (APIs) and drug formulations. Ensure methods comply with regulatory standards such as ICH guidelines.
- Analytical Testing: Oversee analytical testing activities including raw material testing, in-process testing, stability testing, and finished product testing. Ensure all testing is performed accurately and in compliance with established procedures.
- Instrumentation Management: Manage and maintain analytical instruments such as HPLC, GC, FTIR, UV-Vis, etc. Coordinate with vendors for instrument calibration, maintenance, and troubleshooting.
- Documentation and Compliance: Maintain accurate and up-to-date documentation of all analytical activities, including method development reports, validation reports, test records, and laboratory notebooks. Ensure compliance with regulatory requirements and internal quality standards.
- Regulatory Support: Provide analytical support for regulatory submissions and responses to regulatory inquiries. Stay updated on regulatory requirements related to analytical testing and ensure compliance with relevant guidelines.
- Team Management: Supervise and mentor junior staff members within the AR&D team. Provide training and guidance on analytical techniques, instrumentation, and regulatory requirements.
- Cross-functional Collaboration: Collaborate with other departments such as formulation development, quality control, and regulatory affairs to support product development projects and ensure timely resolution of analytical issues.
- Continuous Improvement: Identify opportunities for process improvement and efficiency enhancements within the AR&D function. Implement best practices and new technologies to optimize analytical workflows.
- Quality Assurance: Participate in internal audits and assist in the resolution of findings related to analytical activities. Ensure adherence to quality management systems and drive a culture of quality and compliance within the AR&D team.
- Project Management: Manage multiple projects simultaneously, ensuring timelines are met and deliverables are achieved according to project requirements. Communicate project status and escalate issues as needed to senior management.
- Bachelor\'s or Master\'s degree in pharmaceutical sciences, chemistry, or a related field.
- Minimum of 8 years of experience in analytical research and development within the pharmaceutical industry.
- Strong knowledge of analytical techniques such as HPLC, GC, spectroscopy, etc.
- Familiarity with regulatory requirements from agencies such as FDA, EMA, and ICH.
- Excellent communication and interpersonal skills.
- Leadership abilities with a track record of effectively managing teams and projects.
- Attention to detail and strong problem-solving skills.
- Ability to thrive in a fast-paced and dynamic work environment.
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
- Day shift
- Rotational shift
- Overtime pay
- Yearly bonus
- total work: 5 years (Required)
- Anakapalle, Andhra Pradesh (Required)
- Anakapalle, Andhra Pradesh: Relocate before starting work (Required)
+91 8125394001
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Job Detail
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Job IdJD3256873
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAnakapalle, Andhra Pradesh, India
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EducationNot mentioned
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ExperienceYear