Quality Assurance Manager | Abbott | Mumbai

Job Description

• Responsible as Quality Management Representative for India
• Establish and aggressively drive the Quality Assurance strategy for India by taking ownership and aligning with key Global ADC Quality strategies and direction.
• Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott and Abbott Diabetes Care SOPs and locally developed procedures that govern critical to successful business functions. Recognition that some degree of flexibility to execute activities appropriate to local requirements and market needs is also required.
• Elevates issues or significant events (product performance issues) to the appropriate facility with relevant facts and details sufficient to allow Subject Matter Experts responsible for the product quality and performance to analyze, investigate and provide feedback and corrective actions appropriate to the issue.
• When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, formulate detailed action plans that integrate identified stakeholders, the actions necessary, and the required methods and timelines to successfully correct the problem and prevent the issue from recurring / occurring.  Ensure CAPAs identified during audits or other means are successfully resolved prior to commit due dates.
• Work within India to assist affiliates in audit responses and appropriate corrective actions. Review affiliate audits and responds to assure any similar deficiencies are also addressed.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Respond to manufacturing site requests (eg quality holds, reworks, complaint product returns).
• Organize and develop timely action plans in close coordination with the Area/Regional Customer Service Manager ensuring seamless execution of successful QA strategies for India.
• Develop and maintain a QA status report covering routine department functions and providing updates on key problem resolution initiatives.  Examples may include the status of safety alerts, quality holds, field actions (recalls), and CAPAs. The status report will include currently projected completion dates and will be updated and published as required / when status changes.
• Periodic review of India documents and procedures.
• The position will require the incumbent to build effective relationships with local regulators, agencies, and trade organizations to influence the direction of regulations, requirements, and performance expectations.
• Perform local assessments for new partners (eg distributors) and help ensure processes are in place at those partners to maintain product and process quality.
• Perform Gap Analysis to help drive consistency between affiliates and manufacturing facilities. Evaluate and interpret industry regulations and division policies and develop strategies for ensuring affiliates are compliant

Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.

Desired Profile:

• Medical device, Pharmaceutical, or related industry experience (5 + years) in a QA Role.
• Global cross-functional working experiences required.
• ISO13485:2015 certification.
• Strong knowledge of ISO 13485, ISO 9001, 21CFR part820 and ISO14971
• Experience in distribution warehouse set-up, qualification, and audit.
• Experience in process and documentation audit
• Knowledge and experience in product development, commercialization and manufacturing process in IVD medical devices preferred.
• The ability to communicate fluently/effectively in spoken and written English is a must.
• Ability to develop problem resolution plans that take into account both project variables and potential intangible events so that critical to success deadlines are routinely achieved.
• Must possess a high degree of responsibility and a deep sense of ownership for ensuring the highest level of QA standards. The position will require the ability to rapidly retrieve existing standard operating procedures (SOPs), deploy them as required to facilitate commercial business operations, and in some cases develop procedural solutions to appropriately resolve quality and compliance challenges.

Desired skills/experiences include:

• Familiarity with regulations such as ISO 9000/13485, QSR
• Change management
• Experience in working with matrixed organizations
• Program/project management o Cross-functional/cross-divisional experiences
• Applicable technical knowledge/experience
• Audit evaluations and CAPA resolution planning
• Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problems. o Experience in leading and participating in cross-functional teams tasked with QA problem resolution
• Experience in training curriculum development
• Experienced user of Microsoft Office software: Word, Excel, and PowerPoint

Qualification: Bachelor’s degree minimum, Bio-Engineering, technical or business-related discipline