Senior QA Operations Manager
Senior QA Operations Manager
Location: Limerick
Permanent position
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Senior QA Operations Manager for a leading biotechnology company in Limerick. Join a super team of people and a company that offers exceptional salaries and benefits packages. Let's have a conversation to find out more about what's important to you.
The QA Operations Manager will be responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. Will provide QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. Oversee all batch review activities to support disposition of Products.
Responsibilities:
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: - Master records - Executed records - Failure investigations - Change Controls - SOPs - Validation protocols and summary reports - Incursions
Coordinates QA resource assigned to functional area to meet goals and timings, coordinates prioritization of activities with area management.
Provide technical expertise with respect to cGMP across manufacturing, quality systems, investigations, batch review, product technical transfer, and other areas, as required.
Defines and implements quality standards, systems, and metrics for commercial and clinical operations.
Performs compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
Provides advice, direction and cross functional collaboration on quality issues.
Participates in regulatory and customer audits.
Ensures safety and operational standards are maintained.Education and Experience:
BS in life sciences or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired or QP eligible.
Minimum 10 years' experience in pharmaceutical industry with 3+ of those years to include leadership and/or supervisory experience.For further information on this role please contact Elaine Ferguson on or (phone number removed) Check out all our open jobs on our HERO Recruitment website - (url removed) Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel
Location: Limerick
Permanent position
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Senior QA Operations Manager for a leading biotechnology company in Limerick. Join a super team of people and a company that offers exceptional salaries and benefits packages. Let's have a conversation to find out more about what's important to you.
The QA Operations Manager will be responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. Will provide QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. Oversee all batch review activities to support disposition of Products.
Responsibilities:
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: - Master records - Executed records - Failure investigations - Change Controls - SOPs - Validation protocols and summary reports - Incursions
Coordinates QA resource assigned to functional area to meet goals and timings, coordinates prioritization of activities with area management.
Provide technical expertise with respect to cGMP across manufacturing, quality systems, investigations, batch review, product technical transfer, and other areas, as required.
Defines and implements quality standards, systems, and metrics for commercial and clinical operations.
Performs compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
Provides advice, direction and cross functional collaboration on quality issues.
Participates in regulatory and customer audits.
Ensures safety and operational standards are maintained.Education and Experience:
BS in life sciences or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired or QP eligible.
Minimum 10 years' experience in pharmaceutical industry with 3+ of those years to include leadership and/or supervisory experience.For further information on this role please contact Elaine Ferguson on or (phone number removed) Check out all our open jobs on our HERO Recruitment website - (url removed) Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel