Officer Quality Assurance

Job Opening: Sr. Officer / Executive – Quality Assurance

Department: Quality Assurance

Experience Required: 5-6 years (+1 years of relevant experience in IVD/Medical Devices and exposure in Quality Assurance)

Educational Qualification: Graduate/Post-graduate in Sciences-Life science/Biotechnology/Microbiology / Chemistry/Pharmacy.

Reporting: Manager- Quality

Job purpose: Coordinates and Execute QMS activities and In-Process Quality Assurance (IPQA) program designed to ensure continuous production of products consistent with established standards by performing the following duties and responsibilities.

What we are looking for:

Duties & Responsibilities-

• To perform IPQA activities at shop floor in each and every stage of fabrication and packing.

• Preparation, Review and Control of SOP's, BMR/BPR issuance and Records.

• Responsible for handling market complaints by conducting thorough investigations, implementing effective corrective and preventive actions (CAPA), and ensuring timely resolution to maintain product quality and customer satisfaction.

• Preparation of calibration matrix and calibration schedule

• Review of documents of respective areas and logbooks for adequacy and completeness.QA overview for receipt of material from warehouse to production.

• IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities.

• Review and maintenance of technical documentation & correct implementation.

• Identifying Issues /NC's on the floor which may impact QMS/Product quality and ensure the timely implementation of actions.

• Supports other activities where Change Control, deviation, on-conformance and corrective/preventative actions are raised/initiated.

• Supports inter-departmental training initiatives and training of personnel

• Any miscellaneous job activity assigned by HOD

• Additional QMS

• Necessary change controls are obtained & adequately reviewed before change in any product/process/design etc.

• Timely completion of investigations & action points for Incidents/CAPA and audit observations.

• Ensure Adherence/Compliance to records management policies and procedures as applicable.

• Report the Quality alert and Near miss in process map and inform to Manager during any quality issues observation.

Technical Skills-

• Sound knowledge of manufacturing process of ELISA, Clinical chemistry, Rapid techniques and Hematology Customer (internal and external) driven approach.

• Knowledge of GMP's, regulations and validation methods.

• Knowledge of investigational tools.

• Demonstrated knowledge and application of ISO 9001 & ISO 13485 & Computer skills in MS Office, MS PowerPoint etc.).

• Ability to technically review documents from other areas for departmental impact.

• Other Skills: Time management, Team player, Computer skills, Problem-solving skills, administrative skills, Effective written, verbal and listening communication skills.

How you will thrive & create an impact:

• Maintain 5's in work area.

• Ensure safety requirements are in place all the time.

• Ensure Current Good Manufacturing & Good Documentation practices are followed all the time.

• Review and maintenance of technical quality control documentation & correct implementation.

• Timely intimation of Incidents for Investigation and Non-conformance (NC) closure

• In depth knowledge of tools for investigation of Incidents/NC.

Note: Responsibility may be changed as per instruction of Manager Quality.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

3rd party non-solicitation policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation