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.

• Follows Written Procedures
• Provide assistance and training to floor operators
• Clearly and accurately document activities
• Perform basic math calculations
• Perform real-time batch record review of BPRs during operational execution.
• Complete on the floor audits.
• Track and own batch record cycle completion tracking and adherence.
• Request batch records in advance to plan for operational schedule needs.
• Coordinate completion and delivery of completed batch records to IPQA and Batch Record review.
• Facilitate proper GDP batch record corrections are completed.
• Complete investigations, CAPAs, CCs, AIs in Trackwise as needed.
• Performs cleaning of rooms, tools, and equipment
• Ensure that product meets specifications
• Obtain and Maintain Aseptic Gown Certification.
• Prepare supplies to assist with operational schedule as needed
• Write clear and concise observational memos and assist in investigation of controlled areas
• Read, understand, and review SOP’s and Protocols as required
• Identifies and implements operational optimizations.
• Work with Supervisor to review and correction of area specific executed batch records/log books to meet timely closure of documents.
• Supports and/or lead daily meetings to communicate daily activities and production needs
• Communicates effectively with area leadership and cross-functional departments including maintenance, QC, Microbiology, QC Chemistry, IPQA, and customer departments such as visual inspection/packaging
• Identifies deviations in real time and assists with write up of the issue and investigation in Master Control, taking guidance from IPQA, QEM, and Production leadership
• Possess completive, detailed oriented production mentality and is not satisfied by anything less than perfection
• Thinks creatively with the bounds of cGMP framework to overcome challenges and brings viable solutions to the table vs always waiting to be told what to do

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 and 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.