• QA Specialist / Sr. Product Transfer and Tech Support Jobs in Turkey - 25364708

  • Abbott India Ltd
  • Turkey
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

REQUIREMENTS

Bachelors Degree or equivalent in life science
At least 5 years pharmaceutical experience in the fields of quality assurance
At least 5 years of combined experience in QA, Operation or Technical Function in Pharmaceutical, nutritional, cosmetics or medical devices environment
Relevant experience in GLP/GMP regulatory requirements
Understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
Knowledge of international and local quality system and compliance legislations and standards
Ability to communicate effectively, in English & Turkish, both orally and in writing for both technical and non-technical audience Including National and International Cross Functional Teams
Supplier/Third Party Manufacturing expertise
Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives
Ability to use Quality Risk Assessment and Root Cause Analysis tools
Analytical skills and the ability to organize work in a logical, thorough and succinct manner
knowledge of inspection and auditing standards
knowledge of worldwide GLP/GMP regulatory requirements and industry best practices

Product Transfer

Provide Support for below quality activities during Product transfer including, Technology Transfer plan
Test Method Transfer/Analytical Method Validation/Verification
Process Validation/verification Program
Stability program during Shelf-Life of the product
Microbiological validation studies
First lot quality review for release the validation batches for commercialization
Gather information from the Sending Unit, in order to assemble a data package
Evaluate the information gathered and document findings with respect to product robustness
Provide support for the specification setting to Regulatory Affairs and receiving unit

Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards
Complete technical data package and add specific report, summarizing current product robustness from sending unit and complete the package during technology transfer
QA representative in the New Product Introduction process
Involve in support the quality aspects of the Product Portfolio Expansion Initiatives and Geographic Expansion initiatives and other Non-Centrally Supported Products
To Assist in quality and compliance of the product and process during identification of the commercial manufacturing site and all the technology and/or analytical method transfers and improvements
To provide support for preparation of CMC document for the regional supported products during technology transfer
Liaison between sites QA, commercial affiliates, MS&T and other groups as necessary
Responsible for creation of post-transfer Quality documentation

Technical Support

Provide rapid and expert support to facilitate issue resolution for investigations and compliance issues at EPD sites and TPMs
QA coordinator for Management of Change CR initiator for compliance remediation activities and possible task assignee
Supporting in product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products
Ensure that new or changed specifications comply with regulatory and quality expectations
Liaison with other Regional PT&TS OA as well as other QA functions
Provide support as QA representative in the Product Workstream
Core team members in HIVE and/or QA Community of Practice (CoP)
Coordinate Stability Risk Assessment activities for assigned projects
Serve as quality technical support of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives
Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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