Glenmark Pharmaceuticals
Operations BPR Lead
About Glenmark: Glenmark is a leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark employs nearly 10,000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the competition head-on. Position Summary:
The Operations BPR Lead is responsible for the real time batch record review program in manufacturing as a proactive measure of batch record errors and QE reduction. This individual will also assist with advance request for BPR documents in alignment with the operations schedule to prevent delays in record availability and ability to training and execute steps in advance to improve schedule adherence. In addition, the batch record cycle is not complete until the record has received final review with proper corrections completed. This position will be a batch record and process SME to expedite the batch record collection, completion and close-out, therefore coordination of proper GDP error corrections is critical and tracking of batch record cycle time is a critical process parameter for this role. The position is considered a "working Lead" position meaning that the individual in this role will serve as an SME, by following standard operating procedures (SOP) and batch records in accordance with FDA current Good Manufacturing practices (cGMP). In addition, personnel in this position will support the production operation by assisting with area audits, process review and assist with SOP edits, CAPA closure and investigation completion as needed. Overall Job Responsibilities:
Operations Excellence: Serves as area SME of batch record cycle time Review, correction and close out of area specific batch records Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands Assesses situation and provides accurate recommendations to overcome challenges, reaching out for appropriate cross-functional support when needed Execute batch records and production of material promptly and with the highest quality standards. Maintain documentation and functional work areas to GMP standards. Capable of lifting and moving heavy equipment parts and containers. Innovations: Must be able to adhere to outlined procedures and practices and follow specific instructions. Must possess strong math skills, documentation skills, and organization skills. Must be able to lift up to 40-50 lbs. Must possess good manual dexterity. Must possess basic knowledge of cGMP's. Must be able to transcribe detailed data accurately according to GMP and SOP standards. Must be able to work overtime with little or no notice. Must maintain good attendance. Responsible for maintaining the company's high standards of quality, to meet the day-to-day scheduling needs and have the ability to accomplish the departmental goals Stakeholder: Consistently operates in an ethical and safe manner; compliant with procedures and policies; builds trust; tells the truth; initiates transparency into problems; communicates issues openly. Builds strong, diverse teams; attracts and retains good people; develops and makes people better; empowers others; flawless execution in order to support all the multiple technology transfer running parallel Quality/Output: Continue to drive production and think outside the box to maximize output and try to balance personal life with continue changes on daily tasks requirements. Ownership: Ownership of the process and the products being manufactured. Doing it correctly the first time with pride and quality. Focus on working with your team members on ways to succeed. Education:
High School or GED equivalent required Associate/Bachelor Degree preferred NOTE: Experience in identical level job within a cGMP environment may be substituted in lieu of formal post-secondary education Experience:
3
5 Years experience in cGMP/Aseptic Operations Background Knowledge & Skills:
FDA/cGMP/GDP Must possess time management and organizational skills. Must be familiar with computer applications.
About Glenmark: Glenmark is a leader in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark employs nearly 10,000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the competition head-on. Position Summary:
The Operations BPR Lead is responsible for the real time batch record review program in manufacturing as a proactive measure of batch record errors and QE reduction. This individual will also assist with advance request for BPR documents in alignment with the operations schedule to prevent delays in record availability and ability to training and execute steps in advance to improve schedule adherence. In addition, the batch record cycle is not complete until the record has received final review with proper corrections completed. This position will be a batch record and process SME to expedite the batch record collection, completion and close-out, therefore coordination of proper GDP error corrections is critical and tracking of batch record cycle time is a critical process parameter for this role. The position is considered a "working Lead" position meaning that the individual in this role will serve as an SME, by following standard operating procedures (SOP) and batch records in accordance with FDA current Good Manufacturing practices (cGMP). In addition, personnel in this position will support the production operation by assisting with area audits, process review and assist with SOP edits, CAPA closure and investigation completion as needed. Overall Job Responsibilities:
Operations Excellence: Serves as area SME of batch record cycle time Review, correction and close out of area specific batch records Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands Assesses situation and provides accurate recommendations to overcome challenges, reaching out for appropriate cross-functional support when needed Execute batch records and production of material promptly and with the highest quality standards. Maintain documentation and functional work areas to GMP standards. Capable of lifting and moving heavy equipment parts and containers. Innovations: Must be able to adhere to outlined procedures and practices and follow specific instructions. Must possess strong math skills, documentation skills, and organization skills. Must be able to lift up to 40-50 lbs. Must possess good manual dexterity. Must possess basic knowledge of cGMP's. Must be able to transcribe detailed data accurately according to GMP and SOP standards. Must be able to work overtime with little or no notice. Must maintain good attendance. Responsible for maintaining the company's high standards of quality, to meet the day-to-day scheduling needs and have the ability to accomplish the departmental goals Stakeholder: Consistently operates in an ethical and safe manner; compliant with procedures and policies; builds trust; tells the truth; initiates transparency into problems; communicates issues openly. Builds strong, diverse teams; attracts and retains good people; develops and makes people better; empowers others; flawless execution in order to support all the multiple technology transfer running parallel Quality/Output: Continue to drive production and think outside the box to maximize output and try to balance personal life with continue changes on daily tasks requirements. Ownership: Ownership of the process and the products being manufactured. Doing it correctly the first time with pride and quality. Focus on working with your team members on ways to succeed. Education:
High School or GED equivalent required Associate/Bachelor Degree preferred NOTE: Experience in identical level job within a cGMP environment may be substituted in lieu of formal post-secondary education Experience:
3
5 Years experience in cGMP/Aseptic Operations Background Knowledge & Skills:
FDA/cGMP/GDP Must possess time management and organizational skills. Must be familiar with computer applications.