Validation Executive/Manager Indore: Drive Quality at Knovea Pharmaceutical
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Are you an experienced validation professional looking for a challenging role in the pharmaceutical industry? Knovea Pharmaceutical Private Limited is hiring a Validation Executive/Manager in Indore to lead and execute process and cleaning validation activities for our injectable facility. This is an excellent opportunity to contribute to the quality and compliance of our manufacturing processes.
As a Validation Executive/Manager in Indore, you will play a crucial role in ensuring that our facilities meet the highest regulatory standards. Your expertise in developing and executing IQ, OQ, and PQ protocols will be essential in maintaining the integrity and efficiency of our operations.
Why Join Knovea Pharmaceutical?
- Growth Opportunities: Advance your career in a dynamic and growing company.
- Impactful Work: Contribute to the production of life-saving injectable medications.
- Collaborative Environment: Work with a team of experienced professionals.
- State-of-the-Art Facilities: Utilize advanced technologies and resources.
Key Responsibilities of the Validation Executive/Manager:
- Plan, execute, and document process and cleaning validation activities.
- Develop and execute IQ, OQ, and PQ protocols according to regulatory guidelines.
- Conduct risk assessments and optimize manufacturing processes.
- Perform cleaning validation, process equipment validation, and utility equipment qualification.
- Support audits and collaborate on process improvements.
Essential Skills and Qualifications
To excel in the role of Validation Executive/Manager in Indore, candidates should possess:
- Proven experience in process and cleaning validation within the pharmaceutical industry.
- Strong understanding of regulatory guidelines (e.g., GMP, FDA).
- Experience in developing and executing IQ, OQ, and PQ protocols.
- Ability to conduct risk assessments and optimize manufacturing processes.
- Excellent documentation and communication skills.
- Bachelor’s or Master’s degree in a relevant scientific field.
H3: Detailed Responsibilities
- Process Validation:
- Develop and execute validation master plans.
- Conduct process performance qualification (PPQ).
- Analyze and interpret validation data.
- Cleaning Validation:
- Develop cleaning validation protocols and reports.
- Perform swab and rinse sampling.
- Ensure compliance with cleaning validation standards.
- Equipment Qualification:
- Perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment and utilities.
- Document all qualification activities.
H4: Regulatory Compliance
- Ensure all validation activities are conducted in compliance with relevant regulatory guidelines.
- Maintain accurate and up-to-date validation documentation.
- Support regulatory audits and inspections.
H2: Location and Application Process
- Location: Indore
- To apply, please send your resume to [email protected].
Knovea Pharmaceutical Private Limited is a prominent pharmaceutical company based in Indore, Madhya Pradesh, India. Established on February 17, 2020, it operates as a subsidiary of Symbiotec Pharmalab Private Limited (SPPL), a leading manufacturer of corticosteroids and hormone active pharmaceutical ingredients (APIs). citeturn0search6
Key Highlights:
- Focus Area: Knovea specializes in the development and manufacturing of injectable formulations, aiming to address critical medical needs with affordable and innovative pharmaceutical solutions. citeturn0search1
- Strategic Importance: Serving as a forward integration for SPPL, Knovea enhances the group’s value chain by transforming APIs into finished dosage forms, thereby expanding market reach and product offerings. citeturn0search6
- Collaborations: The company has entered into exclusive agreements with major global pharmaceutical firms for the supply of in-house developed injectable products, ensuring long-term revenue visibility and global market penetration. citeturn0search6
- Manufacturing Facility: Located in Rau, Indore, the state-of-the-art facility is designed to meet international quality standards, equipped with advanced technology for sterile manufacturing and bulk lyophilization processes. citeturn0search0
- Regulatory Compliance: Committed to maintaining high-quality standards, Knovea ensures that its manufacturing processes adhere to stringent regulatory requirements, aiming for certifications from global health authorities. citeturn0search0
- Leadership: The company’s board comprises experienced professionals, including founder-promoter Anil Kumar Satwani, who brings over two decades of expertise in the pharmaceutical industry. citeturn0search6
Through its dedication to innovation, quality excellence, and strategic collaborations, Knovea Pharmaceutical Private Limited is poised to make significant contributions to global healthcare by providing accessible and effective injectable therapies.
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