Operations Investigator - DPI

Cipla • Hauppauge, NY

54d • $21 - $30

About The Position

Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions ( CAPAs ) to prevent recurrence. Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings. Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions. Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations. Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes. Gathering, trending, and analyzing process-related data to drive consistency and timeliness. Training new employees in investigative processes and techniques and documenting all training. Coordinating and/or leading cross-functional meetings with multiple departments. Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same. Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis)

Requirements

• A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required.
• 2-5+ years’ experience
• Proficiency with Microsoft Office, SAP, Track wise.
• Strong analytical skills and proven organizational ability and attention to detail.
• Strong verbal and written communication skills.
• Ability to multitask and work in a fast-paced environment under tight deadlines
• Ability to think analytically, apply sound judgment, and solve problems
• Strong command over written and verbal English is required.
• Interpersonal skills.
• Maintains knowledge of current good manufacturing practices.
• General understanding of equipment, instruments, and systems involved in the manufacturing process.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
• Ability to follow gowning procedure and work in a production environment.

Nice To Haves

• Experience interacting with regulatory health authorities if needed.
• Knowledge of global regulations and standards.

Responsibilities

• Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions ( CAPAs ) to prevent recurrence.
• Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event.
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings.
• Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions.
• Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations.
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures.
• Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes.
• Gathering, trending, and analyzing process-related data to drive consistency and timeliness.
• Training new employees in investigative processes and techniques and documenting all training.
• Coordinating and/or leading cross-functional meetings with multiple departments.
• Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same.
• Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols.
• Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis)

Benefits

• In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees