ABOUT GLENMARK:
Glenmark is a leading player 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 14,000 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:
A Packaging Technician is responsible for the inspection and packaging of filled sterile liquids for commercial distribution and clinical trials. Personnel in this position will support the production operation by handling visual inspection, CCIT, labeling, cartoning, and serialization of filled syringes and vials. This includes but is not limited to operating manufacturing processing equipment by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. Personnel in this position will:
- Follow written procedures.
- Certify and perform manual visual inspector.
- Operate CCIT and PRILM machines.
- Assemble all packaging components.
- Labeling of all product.
- Carton Packing.
- Serialization of all packaged product.
- Clearly and accurately document activities in batch records and logbooks.
- Perform basic math calculations.
- Perform in-process checks and component counting.
- Submit in-process samples to the analytical and microbiology labs.
- Perform cleaning of rooms, tools and equipment.
- Performs specific visual inspections based on clearly outlined checks and specifications for the finished product.
- Responsible to ensure that the product meets specifications.
- Read, understand and review SOP’s and Protocols as required.
OVERALL JOB RESPONSIBILITIES:
Operations Excellence:
- Operate, maintain, assemble & disassemble, clean and set-up applicable production equipment.
- Execute batch records and production of material promptly and with the highest quality standards.
- Maintain documentation and functional work areas to CGMP standards.
- Capable of lifting and moving heavy equipment parts and containers.
- Qualifications:
- Training or Experience:
- Must possess mechanical aptitude.
- Must be familiar with computer applications.
Innovations:
- Must possess knowledge of the metric weight system.
- 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 CGMP 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
KNOWLEDGE, SKILLS AND ABILITIES:
Education:
High School Diploma/Associate Degree preferred
Experience:
0 – 2 Years experience in CGMP Operations Background
Knowledge & Skills:
FDA/CGMP/ Mechanical Aptitude