
Lead Compliance Specialist
1 day ago
The role of Assistant Manager involves ensuring compliance with Good Manufacturing Practices (GMP) guidelines and regulatory expectations. Key responsibilities include reviewing and releasing batches of API, conducting quality assurance checks, and coordinating stability sampling.
Broadly speaking, the job requires reviewing batches of Active Pharmaceutical Ingredients, performing quality control measures, and planning manufacturing activities to ensure compliance with GMP standards.
- Reviewing and releasing API batches, including intermediate stages of production
- Conducting in-process quality assurance checks
- Coordinating area clearance for scheduled manufacturing activities
- Ensuring day-to-day compliance for manufacturing facilities during batch manufacturing activity
- Reviewing BMR related ROA for Release of Drug Substance (Bulks)
- Managing Cell Banks, including issuance, trending monitoring, and reconciliation
- Coordinating CAPA plans/risk mitigation plans, QA Oversight GLP, and Self Inspection Plans
- Preparing Annual Product Quality Review (APQR) reports for all products manufactured at the facility
- Identifying training needs and implementing a training index
- Reviewing and verifying GMP/GLP checks in QC and Manufacturing areas of the Biotech division
Additional tasks may be assigned by the immediate supervisor or HOD from time to time.
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Regulatory Compliance Specialist
21 hours ago
Dholka, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 13,00,000Regulatory Compliance Specialist A critical role exists for a Regulatory Compliance Specialist to ensure product compliance with regional regulations and maintain market access across diverse countries in Africa. Key Responsibilities: Prepare and submit registration and re-registration dossiers as per country requirements. Arrange for samples, packing...
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Lead Quality Assurance Specialist
1 day ago
Dholka, Gujarat, India beBeeQuality Full time ₹ 40,00,000 - ₹ 70,00,000Lead Quality Assurance SpecialistJob Description:As a Lead Quality Assurance Specialist in the Quality Control Lab, you will be responsible for overseeing analytical tests to ensure compliance with cGMP and GLP practices. This includes analyzing raw material samples using various instruments such as FTIR, UV, Polarimeter, KF, Autotitrator, HPLC, GC, and...
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Regulatory Compliance Specialist
7 days ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000Key responsibilities for this role include:Preparing and submitting registration and re-registration dossiers as per country requirements.Submitting various original documents for notarization, chamberization, and legalization.Coordinating with other departments to ensure timely filings and query responses.Post-approval activities, including submission of...
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Technical Support Specialist
1 day ago
Dholka, Gujarat, India beBeeDISTRIBUTION Full time ₹ 40,00,000 - ₹ 70,00,000Technical Support SpecialistThe role of a Technical Support Specialist involves coordinating the distribution of products to various destinations, ensuring timely and accurate deliveries. This position requires strong organizational skills and attention to detail.Key Responsibilities:Product Distribution CoordinationCoordinate product distribution to various...
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Procurement Operations Lead
1 day ago
Dholka, Gujarat, India beBeeProcurement Full time ₹ 6,00,000 - ₹ 8,00,000Job Description:The Procurement Operations Lead is a key member of the procurement team, responsible for overseeing the end-to-end Purchase to Pay process. This includes managing purchase requisitions, procurements, vendor onboarding, invoice processing, GRN, payments, and compliance.Key Responsibilities:P2P Process Management: Manage the entire Purchase to...
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Scientific Research Specialist
1 day ago
Dholka, Gujarat, India beBeeResearch Full time ₹ 15,00,000 - ₹ 20,00,000Key Role: Scientific Research SpecialistThis is a challenging role for an individual who is passionate about scientific research and has experience in analytical chemistry. As a Scientific Research Specialist, you will be responsible for performing a variety of tasks including maintaining and calibrating laboratory equipment, developing and validating...
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Scientific Research Specialist
1 day ago
Dholka, Gujarat, India beBeeTechnical Full time ₹ 9,00,000 - ₹ 12,00,000Senior Technical Specialist Job DescriptionWe are seeking a highly skilled Senior Technical Specialist to support the development and implementation of production processes.Responsibilities:Develop and execute alternate vendor batch execution and process improvement plans.Manage change in batch size, troubleshoot at shop floor, equipment change activities of...
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Technical Lead
1 day ago
Dholka, Gujarat, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000We are seeking a qualified professional to assume the role of Technical Lead. The successful candidate will be responsible for overseeing laboratory operations and ensuring compliance with quality control regulations.This position involves ensuring the accuracy and reliability of test resultsmaintaining inventory management systems for chemicals, solvents,...
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Technology Process Manager Lead
1 day ago
Dholka, Gujarat, India beBeeManagement Full time ₹ 13,75,000 - ₹ 15,12,500Job DescriptionThe Technology Process Manager Lead will oversee the development of Standard Operating Procedures (SOPs), manufacturing records, and regulatory submissions to ensure compliance with quality management standards.This role involves leading technology receiving activities and Quality Management System (QMS) related tasks at the manufacturing...
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Senior Quality Assurance Specialist
5 days ago
Dholka, Gujarat, India beBeeAnalytical Full time ₹ 8,00,000 - ₹ 12,00,000Job Title: Senior Quality Assurance SpecialistWe are seeking an experienced professional to lead our quality assurance team and ensure the highest standards of product quality.Main Responsibilities:Quality Control: Oversee the implementation of quality control procedures, including sampling, testing, and inspection.Process Improvement: Develop and implement...