56 Job openings found

  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, ...

Major Responsibilities: Ø  Quality Management System Implementation and Modification control. Ø  Document Control. Ø  Approval for batch release. Ø  Review and approval of Qualification Document. Ø  Review and approval of Calibration and Validation document. Ø  Planning, execution and compliance of both internal and external audits. Ø  Preparation of audit compliance report.   Job description Minor Responsibilities:   Ø  Review and approval of SMF, VMP and Quality manual. Ø  Review and approval of ...

Internal Job Description Education / Experience  M.Sc. Analytical/Organic Chemistry/Inorganic Chemistry  Min. 5 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment, with exposure to method development and validation activities  Technical skills &  Competencies / Language Technical competence.  Leadership skills.  Analytical ability.  Planning ability.  Communication skills.  Problem solving.  Team building.  KEY ACCOUNTABILITIES  Analysis and approval  Sampling, analysis and ascertaining quality of raw materials, packaging ...

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 ...

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 ...