Abbott Quality Assurance Careers
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Abbott Quality Assurance Careers – BSc & MSc Apply Online

BSc & MSc Biochemistry, Biotechnology, Microbiology, Immunology candidates can apply online at Abbott. BSc & MSc candidates looking for a research career in Biotech companies can apply for this job at Abbott. For more details on Abbott Research Careers check details below:

Job Title: Quality Assurance Manager

Job ID: 30932384

LOCATION/SITE: Mumbai

DEPARTMENT/DIVISION/ UNIT: Abbott Diagnostics (ADD)

GRADE: 16

REPORTS TO: Regional Manager, APAC, Global Commercial QA

EFFECTIVE DATE

PRIMARY FUNCTIONS/ JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES

PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES:

  • Provide aid to Regional QA Manager in planning to preserve an effective Quality System.
  • Take lead in recording, documentation and archival of Quality documents.
  • Identify potential cases of non-conformance internally and externally that could impact ADD-India business continuity.
  • Effective planning and execution of requirements according to Abbott Diagnostics Division QS requirements (Q01.07)
  • Provide support to Regional QA Manager towards effective strategic planning to mitigate possible business risk originating from deviations to meet quality requirements.
  • Achieve EHS goal for the affiliate – 100% compliance to EHS programs of Commentary Drives, New Employee Training, Online Refresher Training Reduction in employee at-fault incidents’ and implement new EHS initiatives for the division.

MAJOR RESPONSIBILITIES:

  • Implementation of divisional high-quality policies in Indian affiliate and deviation (if any) tracking.
  • Make sure the Quality objectives of ADD-India are met.
  • Help Regional QA Manager in maintaining a quality management system up-to-date for ADD-India
  • Responsible for the documentation and communication of internal and external compliance-related information such as changes impacting business continuity of ADD-India.
  • Document Audit non-conformances evaluates impact, propose corrective/preventive actions and implementation of effectiveness check-in a time-bound manner.
  • Coordination between internal functions to make sure all activities associated with Quality compliance is finished in a time-bound manner.
  • Ability to comprehend, interpret, and apply document control principles and procedures to guarantee compliance with Corporate, Regional, ISO regulations and standards with unyielding integrity.
  • Communicate non-conformances to owners, managers, directors, and upper management.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support to Regional QA Manager towards effective planning of Inspection reporting and activities.
  • Update local procedure, forms based on internal process modification or developments.
  • Performs supplier assessment prior contract initiation.
  • Lead qualification and control of new Distributor according to existing procedures and help existing distributors towards compliance with divisional requirements.
  • Provide sufficient support to RA manager towards drafting Quality agreements/contracts.
  • Provide daily QA oversight for third-party logistics providers and spare parts depots.
  • Support management review to assess the health of ADD India quality systems
  • Support Global CAPA team as SME (subject matter expert) to assist affiliates to resolve issues within the APAC region
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JOB SPECIFICATIONS:

MINIMUM SKILL, EDUCATION, EXPERIENCE

  • Bachelor’s degree in life sciences or pharmacy (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is favoured. Masters in the above field will be favoured.
  • Minimum 3-4 years of experience in handling corporate excellent management system function.
  • QA experience in manufacturing will be an added advantage.
  • Internal Quality (ISO 9001:2008 or later standard) Auditor certificate.
  • 2+ year association with a regulated industry (Healthcare preferred). Knowledge of In-vitro medical devices or Medical devices are going to be preferred.
  • Strong working knowledge requirements of Drugs and Cosmetics Act, 1940 and Rules, 1945.

KEY REQUIREMENTS:

COMPETENCIES

  1. Effective coordination skills together with internal functions of ADD-India.
  2. Document archiving and control.
  3. Effective Audit planning.
  4. Fantastic communication skills and basic working knowledge of MS-office.

ACCOUNTABILITY / SCOPE:

SUMMARY OF POSITION:

The position will be key in keeping the highest level of compliance towards Quality System needs of Abbott Diagnostics division. The position will play a significant part to maintain a successful coordination among all different business purposes to make sure divisional and company demands in addition to India quality demands are satisfied.

Apply Online

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