TPM TT/QA Manager Abbott Laboratories

JOB DESCRIPTION:

Abbott is a global healthcare company committed to helping people live not just longer, but better. We employ around over 100,000 people in 150+ countries with a diverse portfolio spanning pharmaceuticals, nutrition, diagnostics and devices.

At Abbott, you have the opportunity to make a positive impact on the world through challenging and rewarding work as part of a highly successful and trusted organization that is shaping the future of health. Realize your potential!

Purpose of R le

• Management of TPMs and Technology transfer activities at TPMs in EMEA region.

• Support new product launches, new product introductions, GeoEx of existing products from one country to another within EMEA region with activation of new upcoming TPMs into EMEA from portfolio growth.

Minimum Education Qualification for the role

Bachelor s degree in science; Pharmacy or microbiology or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with enough exposure to pharmaceutical or related industries

Minimum Experience/ background for the role

Total combined years: Combined 12+ years in QA, Operations or Pharmaceutical engineering. Minimum 10 years in pharmaceutical manufacturing plant and minimum 5 years of experience in Quality Assurance / Quality Control function / department.

Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.

Knowledge of international and local quality system and compliance legislations and standards.

Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid and injectable products.

High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices.

Build Organization & inspire people.

Core Responsibilities

1- As TPM QA

• Quality management, oversight at TPM in the EMEA region, for delivering quality products through reliable supply chain with on-site visits on set frequency and business needs.
• Responsible to support establishing and implementing management processes at Third Party of medicinal products, medical devices & consumer health products per Regulatory & Abbott EPD contractual requirements.

• QA lead in new product introductions meetings and localization projects for smooth execution and launches from contract manufacturing sites from product acquisition, in-licensing deals and or distribution deals.

• Responsible for monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical agreements are adhered / followed by assigned TPMs.

• QA lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM sites.

• QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine quality requirements like GMP audits, new projects or initiatives.

• Primary contact for communication / resolution of TPM quality issues and management elevation as needed.

• Responsible for updating and maintenance of regional approved supplier listing.

As Tech transfer QA

2.1 Product Transfer:

• QA Lead 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.

As Tech transfer QA

2.1 Product Transfer:

• QA Lead 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.
• Responsible for ensuring that all the quality activities during technology and/or analytical method transfer are timely completed 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.
• 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.

• Provide Quality Technical Leadership for process and regulatory deficiency issues.

Liaison between sites QA, commercial affiliates, MS&T and other groups as necessary

2.2 Technical Support:

• Provide rapid and expert support to facilitate issue resolution for investigations and compliance issues at 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.