SUN PHARMA Billerica, Massachusetts, United States (On-site)

Job Summary

Execute plans, schedule, and expedites the visual inspection, labeling and packaging of parenteral pharmaceutical along with dermatological products to meet sales requirements according to current Good Manufacturing Practices (cGMPs) and following Standard Operation Procedures (SOPs). This position will also manage the warehouse shipping/receiving team.

Area Of Responsibility

• Directly oversee shift leads and floor personnel through regular presence on the floor in the inspection/packaging areas as well as the warehouse to improve safety, optimize quality and elevate performance.
• Manage all kit inspection, packaging and labeling operations in accordance with direction from the Operations Director and commercial forecast.
• Plan, Lead, manage, prioritize and organize work in the ILP and warehouse operations teams.
• Work cohesively with the Sr. Production manager to ensure packaging area scheduling are in alignment.
• Able to be a SME for Visual Inspection during FDA/Health Canada/EU inspections.
• Assign daily duties to group to accomplish production goals utilizing personnel effectively.
• Ensure all staff training and qualifications for Visual Inspection are up to date.
• Resolve routine to complex inspection and packaging issues and/or equipment problems with staff and/or other departments in a timely fashion
• Revise batch records and standard operating procedures (SOP's) as needed to improve efficiency and quality of manufacturing/packaging process
• Use systems like SAP, Track-Wise, EDMS and Master Control etc.
• Initiate/Author and be able to complete Deviations, Change Control, CAPA's etc.
• Update computer data for packaging department to record production inventory, results, dates, problems, etc.
• Review all in-process documentation for accuracy
• Ensure proper operation of Inspection/Labeling/Packaging equipment
• Plan and order supplies for production to assure the timely completion of production goals
• Make recommendations on efficiency and cost as appropriate
• Work under minimal direct supervision, utilizing some standard procedures along with own judgment
• Prioritizes safety and maintains good housekeeping in the ILP working area and warehouse.
• Oversee all phases of the Change Control process for owned changes
• Hire, train, manage and motivate staff to meet production and warehouse demands
• Other duties as assigned

Work Conditions:

• Office
• Shop/Shipping area
• Controlled/Manufacturing area

Physical Requirements:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
• Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
• Close, color and peripheral vision, depth perceptions, ability to adjust focus
• Correctable 20/20 vision
• Ability to visually inspect small products and print
• Be able to multitask
• Operate label application machinery, thermal transfer printer, computer, serialization and heat sealing equipment
• Operate computer/office machines
• Proper gowning, Safety shoes, safety glasses, gloves
• Lift up to 30 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

• B.S. required
• Must possess current, valid class D Driver's license
• Ability to operate and maintain all process equipment
• Familiarity with FDA cGMP, SOPs and ISO standards
• Knowledge of pharmaceutical labeling/packaging equipment and warehouse operations

Experience

• Minimum 8-10 years related experience with minimum 4- 6 years in a supervisory and/or managerial role required
• Direct experience with manual visual inspection for small volume parenteral required
• Strong computer skills

The presently-anticipated base compensation pay range for this position is $130,000 - $142,500 +15% bonus target. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan and company match; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.