Central Lab QA Auditor

Job Description

This position will be filled with an experienced individual who promotes and leads a quality driven culture across Syngene Central Laboratory (CLAB) Services. The role involves regular internal and external audits, verification that all operations meet relevant standards/good practice guidelines, and acting as a Lead QA on all quality issues. This position also may lead and/or support departmental and/or company Special Projects/Initiatives.Job Overview:

• This position will be filled with an experienced individual who promotes and leads a quality driven culture across Syngene Central Laboratory (CLAB) Services.
• The role involves regular internal and external audits, verification that all operations meet relevant standards/good practice guidelines, and acting as a Lead QA on all quality issues. This position also may lead and/or support departmental and/or company Special Projects/Initiatives.
• Review daily internal quality control and verify corrective action in case of deviations.
• Review QC data in terms of log books, LJ charts etc., daily and monthly basis and ensure timely documentations by the technical staff.
• Actively participation in root cause analysis of internal, external queries and NCs
• To ensure active participation of team members for internal & external audit by keeping the lab ready for audit procedures.
• Ensure that the technical section is complying with testing and calibration requirements as laid down in the SOPs.
• Perform QA oversight on the compliance to preventive maintains plan and calibration schedule
• Verify maintenance and calibration status of the equipment in coordination with authorized user of the equipment.
• Assure standard and universal precaution including PPE Biomedical waste management guidelines are followed by team members.
• To implement and follow laboratory QMS,NABL and ISO 15189:2012 standards.
• Review and submit data related to Quality indicators to Lab Director /QA HOD/Manager on monthly basis.
• Prepare the department for internal and external audits under supervision of Manager/ QA HOD.
• Ensure the activities are recorded accurately and in a timely manner and records maintained in legible and neat by the team members.
• Reporting of inability to cope with or comply with any S.O.P. / Work Instructions to Lab in charge
• QA oversight on qualification of analysts, analysis of quality control samples and the maintenance of calibration and QC data

Essential Job Duties:

• Develop and revise CLAB QA SOPs and other Quality Documents
• Host/Support/Participate Client/Regulatory Audits along with Manager/ QA Head.
• Perform /support Internal systems /Vendor audits as assigned
• Train and/or mentor other QA/ QC/ Technical staff on regulatory technical standard & guidance and Syngene Corporate Quality Policies.
• Lead QA departmental and/or company special projects/initiatives in CLAB
• Provide Quality Issues support
• Perform trending & risk assessments of Quality metrics.
• Identify process improvement opportunities
• CLAB Archives Administration
• Perform QA Review of Process /Technical SOPs and other Documents
• Participate or lead QA data integrity / Remedial Investigations.
• Perform trending on quality & risk management
• Performs some other assigned aspects and/or training tasks:

Educational Qualification: Masters in Life sciences / Pharmaceutical sciences /Biotechnology or related technical discipline.Technical/functional Skills:

• Develop and revise GCP QA /CLAB QA SOPs and other Quality Documents
• Host/Support/Participate Client/Regulatory Audits along with GCP QA Head.
• Perform /support Internal systems /Vendor audits as assigned
• Train and/or mentor other QA/ QC/ Technical staff on regulatory technical standard & guidance and Syngene Corporate Quality Policies.
• Lead GCP QA departmental and/or company special projects/initiatives in CLAB
• Provide Quality Issues support
• Perform trending & risk assessments of Quality metrics.
• Identify process improvement opportunities
• CLAB Archives Administration
• Perform QA Review of Process /Technical SOPs and other Documents
• Participate or lead QA data integrity / Remedial Investigations.
• Perform trending on quality & risk management
• Performs some other assigned aspects and/or training tasks:

Experience: 6-9 years.Behavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
continuous improvement facilitationsopquality assuranceequal employment opportunitycalibrationdecodingroot cause analysisroot causecommitment towards workbioanalytical