51 Job openings found

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 ...

Position:          Dy. Manager - Quality Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma API  Responsibilities: Quality Management System (QMS)   Establish, implement, and maintain an effective Quality Management System in line with cGMP, ICH, USFDA, EU-GMP, WHO, and other regulatory requirements. Ensure compliance with SOPs, policies, and ...

Position:          Production Officer (Documentation) Location:         Vapi Experience:      5 - 8 Years Industries:       Pharma - API Responsibilities. Handling of QAMS, DMS activities Prepare SOP, BMR, ECR and all related docs. as per CGMP TO maintain & review all document like change control, Incident with compliance report Involvement in ...

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, ...