50 Job openings found

Key Responsibilities   1. Quality System Management and Compliance: Implement, maintain, and monitor the company's Quality Management System (QMS) as it relates to API manufacturing. Ensure all processes, procedures, and documentation comply with cGMP, regulatory guidelines, and corporate policies. Conduct routine inspections and on-line process checks to ensure adherence to standard operating procedures (SOPs) and ...

Preparation of Certificate of Pharmaceutical Product. Expertise in liaising, coordinating inspections with regulatory agencies (FDA ISO    9000) Knowledge of Microsoft Office, Microsoft Excel, ERP etc. Goal Oriented and Results Driven Team Leader. Expertise in writing, reviewing & approving lab procedures / documentations, Out off   Specification                     reports, batch records, protocols, etc. Review of QC related ...

  Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing. Key Responsibilities Quality Systems & Compliance Implement, ...

Position:        Sr. Manager - QC  Location:        Ahmedabad Experience:    12 - 18 Years Industries:     Pharma   Responsibilities:         Lead and oversee the entire Quality Control department operations. Ensure compliance with cGMP, regulatory guidelines, and company quality standards. Review and approve analytical methods, specifications, and validation protocols. Supervise raw material, in-process, and ...

Key Responsibilities: 1. Quality System Management Implement and maintain the Quality Management System (QMS) in compliance with ISO 17025 / GLP / GMP / NABL standards. Prepare, review, and control QA-related documents such as SOPs, policies, forms, and records. Ensure timely calibration, maintenance, and validation of laboratory instruments. Conduct internal audits and coordinate external audits ...

Position:       Executive/ Sr. Executive - QA (Qualification And Validation) Location:      Sarigam Near by Vapi. Experience:  8 to 10 Years Industries:    Pharma    Responsibilities:  Led the qualification and validation of HVAC systems to ensure compliance with regulatory standards and maintain optimal environmental conditions for pharmaceutical manufacturing. Monitor the qualification process for water systems ...

The job description is as below: Finding business partner for plant In-Licensing. Introduction of New Third Party and Loan Licensing (Out Licensing) Having contacts with Formulation suppliers of various dosage forms. Knowledge of transfer price negotiations, current API rate of all dosage forms. To handle QA activities of Loan License / P to P sites ...

Position:        QA Manager Location:        Ankleshwar Experience:     15 - 18 Years Industries:     Pharma - API   Responsibilities: Day to Day planning and execution of various activities in QA Execution/review/Approval & monitoring of process validation activities. Preparation, review, Approval of process validation Protocol/Report. Preparation, review and Approval of Annual Product Reviews Handling of Change Controls ...

  Position:        QC Manager (Injectable) Location:          Daman Experience:     5 - 10 YEARS Industries:       Pharma Responsibilities: Experience in vaccine and biological (Mabs) manufacturing, Handled greenfield / brownfield – QC lab, qualification and validation of QC lab and instruments, Preparation and review of all QC documents such as SOPs, protocols, reports, etc., USFDA and EU audit handling exposure, ...

Ensuring compliance to cGMP, GDP for plant operations Review and compare global quality policies, procedures and directives and regulatory guidelines with site procedures. Identify gaps and ensure updation of site procedures. Successfully managed Regulated and Semi-regulated market audits Drive team to productivity and reduce attrition rate; capable of sourcing candidates for own team in minimum timeline Tracking and investigations of OOS / OOT from manufacturing site on timely manner Checking compliance of response given to regulatory observation and queries Review and approve standard operating procedures, specification, master plans, standard testing procedure, protocols and reports Coordination with manufacturing, purchase, regulatory and R&D for smooth and timely execution of exhibit and commercial batches and new product launches. Review and completion of change controls of products, process, test method, equipment and facilities. Respond to inspection observation and business affiliate queries. Provide updates to regulatory agencies on compliance to response. Drive internal audit, ensure compliance to schedule and timely CAPA implementation.  Approve risk management protocols and reports pertaining to various quality systems Organize and lead team to execute timely batch processing through validation and checks Manage and respond to market complaints adequately Perform Risk analysis and management at regular intervals Have proven ...