QA Inspector I

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Description:

• The QA Inspector (Manufacturing) is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing in compliance with established specifications.

Essential Functions:

• Responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications
• Perform in-process testing (e.g. weight thickness hardness disintegration friability etc.) as per manufacturing batch record instructions.
• Perform room and equipment checks (where applicable) prior to each stage of manufacturing process as guided through written procedures.
• Perform AQL Blend sampling In-process Sampling and inspections as required.
• Prepare in-process and finished product samples (where applicable) for QC lab following detailed documentation procedures and delivering them to QC lab.
• Maintenance of standard weights and perform daily verification of balances which includes physically carrying ability of 100 kg (25 Kg x 4 Nos) weights for multiple balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records (temperature and humidity data calibration and PM records Pest control records and contractor related functions).
• Review of online batch records in terms of completeness of signatures entries and actual reconciliation / yields prior to initiation of next processing step.
• Verification of functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances/discrepancies to management if applicable.
• Other duties that management may assign from time to time.

Education:

• Associate degree diploma or equivalent (required); strong background in science preferred.

Experience:

• 23 years of pharmaceutical industry experience particularly in manufacturing or packaging (preferred).

Skills:

• Proficient user of personal computer hardware and software applications such as Microsoft Office SAP and other business applications.
• Strong knowledge of GMP regulatory requirements (FDA) and pharmaceutical manufacturing processes.
• Prior experience in RX and generic pharmaceutical manufacturing/packaging is a plus.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage spelling grammar and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written verbal)
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

About Cipla

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 Indias 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. Driven by the purpose Caring for Life Ciplas focus has always been on making affordable world-class medicines with a reputation for uncompromising quality standards across the the last 85 years Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary 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 October 2020 InvaGen established its project site in Fall River Massachusetts to support the launch of Ciplas respiratory business in the United States.

Equal Opportunity Employer

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race Color Religion Sex Sexual Orientation Gender Identity National Origin Age Genetic Information Disability Protected Veteran Status or any other legally protected group status. At Cipla we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience skills education and budget. Salary range may vary based on geographic addition to base salary this position may be eligible for benefits and participation in a bonus program based on performance and company results.