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Compliance Officer - Quality Assurance - Formulations - Pharma

2.00 to 4.00 Years   Chennai   11 Nov, 2022
Cornerstone India
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaFinance / Accounts / TaxQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    QA Compliance Officer ( Formulations (OSD) )Job Responsibilities :1. Ensure all quality reports are written and approved within the required timeframe by the department2. Lead & Review Process investigations and Risk Assessment Documents to ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.3. Raise, investigate and review compliance documents e.g., Change Controls, Deviations, SCARS, Reject Notices, and CAPAs.4. Conduct routine Quality Audits of the department to ensure compliance and be proactive in resolving issues which may arise.5. Provide and update existing Quality Procedures such as Standard Operating Procedures (SOPs) in line with GMP regulations6. Contribute to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.7. Support or where necessary lead Quality based projects within the department including working as part of a multidisciplinary team as required.8. Participation in the self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place.9. Assist the Procurement team in the creation of Approved Supplier PacksSupport and participate in Change Control meetings and the monthly Quality Management & Review meeting10. Any other duties assigned by the direct line managerCOMPETENCIES:1. Excellent Communication and Interpersonal skills2. Analytical, Methodical and structured approach to organising their work3. Process Improvement Mindset essential4. Ability to manage multiple critical priorities5. Exceptional Team Playing skills with the ability to manage multiple stakeholders6. Displays flexibility and shows willingness to learn and do that little bit extra QUALIFICATIONS:1. Bachelors/PG degree in Quality or Science based discipline2. Minimum of 2-4 years experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential3. Experience working in pharmaceutical preferred however medical device industry experience will also be considered4. Excellent Report Writing and IT Skills5. Demonstrated hands on experience of delivering a best-in-class QA function in a similar role,

Keyskills :
draftinglegalcompliancefilingformsstandard operating procedurescontinuous improvement facilitationquality auditreport writingchange controlrisk assessmentresolving issuesregulatory audits

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