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Specialist - Quality Operations
6-8 years
Hyderabad / Secunderabad
1 vacancy
Specialist - Quality Operations
Novartis
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
About the Role:
This position is responsible for quality oversight of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP.
Key Responsibilities:
Develops and maintains a Quality Assurance Agreement in cooperation with the external partners.
Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments.
Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners.
Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc. according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit of contract manufacturers and act as QARP and or FURP as required.
Ensures that change requests, either from contract manufacturer or from ADACAP, are managed according to the Quality Agreement and ADACAP change control procedures from receipt, through to the implementation and closure.
Reviews third party documents from a quality point of view (i.e. product test methods, specifications, and protocols/reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, etc.).
Performs, coordinates or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs. Responsible for compiling product quality reviews in cooperation with external partners. Initiates and drives quality improvement projects as required.
Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations. Develops related procedures or provides input as needed.
Escalates significant quality incidents and supply risks as per ADACAP and Novartis escalation policies to management. Responsible for reporting and trending of defined key performance indicators per assigned contract manufacturers. Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
About the Role:
This position is responsible for quality oversight of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP.
Key Responsibilities:
Develops and maintains a Quality Assurance Agreement in cooperation with the external partners.
Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments.
Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners.
Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc. according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit of contract manufacturers and act as QARP and or FURP as required.
Ensures that change requests, either from contract manufacturer or from ADACAP, are managed according to the Quality Agreement and ADACAP change control procedures from receipt, through to the implementation and closure.
Reviews third party documents from a quality point of view (i.e. product test methods, specifications, and protocols/reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, etc.).
Performs, coordinates or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs. Responsible for compiling product quality reviews in cooperation with external partners. Initiates and drives quality improvement projects as required.
Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations. Develops related procedures or provides input as needed.
Escalates significant quality incidents and supply risks as per ADACAP and Novartis escalation policies to management. Responsible for reporting and trending of defined key performance indicators per assigned contract manufacturers. Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers.
Role Requirements :
Essential Requirements:
At least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing
At least 3 years of experience in a Quality Assurance function
Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing
Proven track record of maintaining quality oversight on external partners
Experience with biological manufacturing would be an additional asset
Good communication skills
Team and consensus builder, with definitive and authoritative decision making ability.
Desirable Requirements:
Higher university degree (Masters, PhD or equivalent) in Pharmaceutical, Chemistry, Biochemistry, or another related science
Languages: Fluent in speaking and writing in English
At least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing
At least 3 years of experience in a Quality Assurance function
Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing
Proven track record of maintaining quality oversight on external partners
Experience with biological manufacturing would be an additional asset
Good communication skills
Team and consensus builder, with definitive and authoritative decision making ability.
Desirable Requirements:
Higher university degree (Masters, PhD or equivalent) in Pharmaceutical, Chemistry, Biochemistry, or another related science
Languages: Fluent in speaking and writing in English
Employment Type: Full Time, Permanent
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14%
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Quality Operator salary at Novartis
reported by
3
employees
with 7-13
years exp.
₹6.2
L/yr - ₹12.5
L/yr
372%
more
than the average Quality Operator Salary in India
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What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
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