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
DEPARTMENT/DIVISION/ UNIT: Abbott Diagnostics (ADD)
REPORTS TO: Regional Manager, APAC, Global Commercial QA
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.
- 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
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.
- Effective coordination skills together with internal functions of ADD-India.
- Document archiving and control.
- Effective Audit planning.
- 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.
Editor’s Note: Abbott Quality Assurance Careers, msc biotech jobs, immunology vacancies, immunology posts, microbiology careers, quality assurance jobs, QA vacancies. Make sure you check out the Biotecnika Times Newsletter, Podcast and all of the social media profiles.