Section Head - Production

About the role

Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time.

Responsibilities

• Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards
• Review planned production vs. actual production daily and control the production activity of the plant as per the schedule
• Prepare production schedules for the block and ensure adherence to the schedules
• Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts
• Execute new product & product transfer by performing gap analysis to meet market requirements
• Review in-process analysis on daily basis to enhance the quality of final product
• Maintain unit operations and processes to avoid failures
• Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue
• Optimise the utilisation of manufacturing consumables as per the budgets to reduce overhead cost
• Conduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints
• Evaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown
• Prepare, review and update GMP documents to meet regulatory compliance and quality of product
• Handle investigations, OOS, OOT, change controls, deviation & CAPA in the block
• Prepare and review the qualification, validation and other documents to maintain GMP
• Participate in the internal and external audits to assure system control
• Review new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations
• Ensure adequate and trained manpower availability across shifts to ensure production continuity
• Effectively utilise manpower in each shift by understanding workload and requirement to get desired production output
• Plan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance
• Monitor employee and workplace safety to maintain safe environment
• Avoid accidents in plant by ensuring all operations are performed as per safety norms
• Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule
• Implement manufacturing excellence practises for continuous improvement
• Ensure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue
• Track monthly change over time of machine to sustain the baseline
• Prepare the plans for utilization of bottleneck machines to reduce the time loss
• Monitor the yield of runner products to ensure yield above baseline

Qualifications

• Bachelor’s degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
• Minimum of five to nine (5-9) years’ experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.

Skills

• Understanding of machines used in pharmaceutical manufacturing
• Influence decision making and facilitate completion of work towards the achievement of the business plan and goals
• Effective interpersonal relationship skills and the ability to work in a team environment
• Capable of conducting troubleshooting, investigations and root cause identification and analysis
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels
• Proficient in computer skills and software applications such as Microsoft Office tools
• Experience using SAP business system and applications is a plus
• Experience in Inhalation products (MDI) is a plus

Benefits

• No remote work available
• Working condition This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
• The role may be assigned on a work-shift basis where required (Day, Evening, Night).
• Weekend or Holiday work may be requested or required based on business needs.

Pay

$83,200 – $104,000

Schedule

Must be willing to work in a pharmaceutical manufacturing setting. Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management.

Global Company

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

About InvaGen Pharmaceuticals

InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Equal Opportunity and Affirmative Action Employer

Cipla, Inc. is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.