Total 17 job vacancies by Par Formulations

1. Responsible for Microbiology operation and implementation of approved procedures in Laboratory.

Responsible for sample management, media and culture management.

2.Responsible for preparation and review of Analytical method validation protocols for MLT, BET, Sterility, Bioburden and other Microbiological methods.

3.Responsible for Maintaining Laboratory review of Documents and timely submission of Laboratory documents for Archival.

4. Ensure timely completion of method validation of all the samples.

5. Coordinate with cross functional team for planning and effective execution of Method Validation activities and support manufacturing related activities in Microbiological studies.

6.Responsible for maintaining, reviewing and evaluation of GLP compliance in laboratory and take effective measures as a continuous improvement program.

7. Trouble shooting and supervision of team members involved in sample management, media and culture management related testing activities.

8.Review and submission of document to regulatory department for filling and regulatory approvals.

9.Support and participate in internal, customer and regulatory inspection and ensure appropriate CAPA initiated and implemented.

10.Evaluate and approve change control, deviations and CAPA raised by Microbiology department and other departments and identify actions to be implemented.

11.Ensure monitoring of utilities required for manufacturing process as per approved schedule and carryout data trending and analysis.

12.Participate in quality improvement programs and support QA function to execute quality related projects.

13. Prepare departmental budget and maintain adequate inventory of consumables.

• Incumbent will be responsible for review of Microbiological Records, like ROA's of RM, PM, FP, In process samples, etc.
• Incumbent will be responsible for Data management for trend preparation, review of Logbooks used in Microbiology Laboratory.
• Incumbent will be responsible for Document Management i.e. Issuance, review and archival after report approval.
• Incumbent will be responsible for QMS initiation like Change Control and CAPA's.

Plan and coordinate day-to-day for production to meet the company’s expectations for safety, productivity, quality, and goal achievement and exceed our customers’ expectations.

Responsible for production schedule, material arrangement and release follow-up, to dispatch the products on time.

Responsible to maximum utilization of resources.

To receive 3 months commercial rolling plan from SCM and one month R&D plan from Project team for production schedule.

Responsible to prepare production schedule and share with CFT with month commitment.

To follow Document team and CFT for document approval as per production schedule.

To create and release process order for commercial, validation, submission, and engineering batches in ERP system.

1) Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).

2) Conducting quality examination in regular intervals by performing in-process checks during the production process.

3) Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing.

4) Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan.

5) Ensuring the compliance and performing calibration of IPQC-Instrument.

6) Acknowledgement of Maintenance request and performing the impact assessment before closure.

7) Performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room.

8) To review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.

Responsible to perform the supervisor activity for cleaning, line clearance and dispensing during routine operations.

ERP updation for all warehouse transactions. Updation of Locations in ERP as per physical.

Ensure the compliance and completeness of activities in internal and external warehouse areas.

Ensure to perform and verification stock cycle counts of as per schedule for material available at external warehouse.

Obtain On the job and SOP training from Supervisor / Head of the department.

Follow the Supervisors instruction, company regulation and cGMP requirements.

To ensure the documentation is done online and accurate.

To ensure all warehouse records are filled and signed online by the personnel.

Any other activities assigned by the Supervisor / Head of the department.

Knowledge having current good manufacturing and regulatory exposure.

US-FDA Exposure

Perform the dispensing activities through Formweigh.Net system

Responsible to perform the supervisor activity for cleaning, line clearance and dispensing during routine operations.

ERP updation for all warehouse transactions. Updation of Locations in ERP as per physical.

Ensure the compliance and completeness of activities in internal and external warehouse areas.

Ensure to perform and verification stock cycle counts of as per schedule for material available at external warehouse.

Obtain On the job and SOP training from Supervisor / Head of the department.

Follow the Supervisors instruction, company regulation and cGMP requirements.

To ensure the documentation is done online and accurate.

To ensure all warehouse records are filled and signed online by the personnel.

Ensure the online documentation in warehouse activity.

Perform the dispensing activities in the Formweigh.Net system.

Stage review of executed BMR/BPR and compliance.

Line clearance of dispensing activity.

EMS alarm acknowledge and report generation for batch.

Ensure the online documentation in warehouse activity.

Co-ordinate with Production & PPIC department for dispensing priority.

Keep area ready to face internal, External, and regulatory audits and inspections.

Responsible to perform and verification stock cycle counts as per schedule.

Receipt and dispatch of Finished goods.

Ensure the online documentation in warehouse activity.

Perform the dispensing activities in the Formweigh.Net system.

Stage review of executed BMR/BPR and compliance.

Line clearance of dispensing activity.

EMS alarm acknowledge and report generation for batch.

Ensure the online documentation in warehouse activity.

Co-ordinate with Production & PPIC department for dispensing priority.

Keep area ready to face internal, External, and regulatory audits and inspections.

Responsible to perform and verification stock cycle counts as per schedule.

Receipt and dispatch of Finished goods.

Coordination with QC person for sampling of Raw & Packing materials.

Dispensing of raw material and packing material as per Batch document and SOP.

Perform the dispensing activities through Formweigh.Net system

Responsible to perform the supervisor activity for cleaning, line clearance and dispensing during routine operations.

ERP updation for all warehouse transactions. Updation of Locations in ERP as per physical.

Obtain On the job and SOP training from Supervisor / Head of the department.

Key Accountabilities -

Investigations and Ethics Hotline

• Works closely with other functions to conduct corporate investigations adhering to the Company’s investigation procedure. It includes the following:
  • Assess concern and determine the need for interim corrective actions.
  • Develop investigation work plan & interview questions.
  • Conduct fact-finding by reviewing documents and electronic communication data.
  • Conduct confidential interviews.
  • Prepare investigation report, including root cause analysis, recommended corrective and disciplinary actions.
  • Schedule and conduct readout meetings with key stakeholders.
  • Update Investigations Case Management System with all supporting investigation files.
  • Track completion of action items
• Manage and monitor the Investigations Case Management System and Ethics Hotline through strategic partnerships with Corporate Compliance and relevant business departments. Ensure that all cases are documented and supporting documents are uploaded in the system, reporters received response upon closure of the investigations.
• Tracks completion of corrective actions working closely with HR, Internal Audit, Corporate Compliance, Quality and other functions. Updates the system with the supporting documents to document completion of corrective actions.
• Works closely with Corporate Compliance department to prepare quarterly investigative reporting and trends to Executive Reporting Committee.
• Provide required documentation for internal and external audits of the Ethics & Compliance Hotline. Review and supply summary and detailed case information to support reporting to senior management or Board of Directors.

Data Analytics, Reporting and Collaboration

• Collaborate with Compliance organization and relevant business stakeholders to identify areas of risk, monitoring opportunities and areas of improvement for Compliance, HR and/or operational activities such as enhancements to policies/procedures, processes, training or technology.
• Provide investigation data and trends for Global Compliance Committee, the Board of Directors reports, due diligence requests or requests from the Legal department.
• Works with Endo’s legal team to ensure the information requested by legal is provided in a timely manner.

Policies, Procedures and Training

• Serve as a subject matter expert and provide analyses of key activities, processes, and policies/procedures to maintain and improve Endo’s processes and controls.
• Assists in implementation of appropriate policies and procedures designed to improve control environment at Endo India and ensure consistency and timeliness in the investigation and disposition of allegations, complaints and reports.
• Conducts or facilitates periodic training to educate team members on the investigations process and encourage speak up culture.
• Promotes awareness of various channels employees may raise concerns at Endo.

Compliance Monitoring & Risk Assessment

• Perform regular monitoring & review to check the effectiveness and compliance of OFAC sanctions controls.
• Perform regular monitoring & review to check the effectiveness and compliance of Due Diligence process.
• Perform regular monitoring & review of all payments made by the company to Third Party Intermediaries.
• Collaborate with the Global Compliance team to document findings and corrective actions.
• Support Global Compliance team to perform yearly Compliance Risk Assessment.

Qualifications -

Education & Experience

• Bachelor’s Degree required with 10-12 years of compliance, legal and/or forensic accounting/auditing field.
• Extensive experience conducting investigations into compliance, legal and HR matters in multinational companies.
• Strong educational credentials with an advanced degree such as JD, Accounting degree, CA, CPA and/or CFE preferred.

Knowledge

• Working knowledge of various laws, regulations, and industry guidance that affect Endo’s compliance program, including Anti-bribery and Corruption laws, FCPA, India local laws and regulations.

Skills & Abilities -

• Ability for communicate in both verbal and written form with all levels of management and employees, including demonstrated excellence in writing investigative reports.
• Ability to evaluate complex health care compliance and HR issues and make appropriate recommendations. 
• High analytical thinking with demonstrated talent for identifying and analyzing critical risk areas.
• Ability to work with large amounts of data to analyze information while still seeing the “big picture”.
• Must possess excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues. 
• Confidence to handle difficult conversations, pressure, and deadlines.
• Excellent interpersonal, communication, presentation, influencing, negotiation and mediation skills.
• Able to prioritize and align the organization against goals and objectives; ensures rigor in operational excellence; and focuses on outcomes with clear measures and metrics.
• Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities, facilitating the implementation and acceptance of change within the workplace.
• Fully engaged and self-starting.  Possess a high energy level and strong work ethic with a commitment to continuous improvement in a dynamic environment that strives to exceed expectations.  Demonstrated ability/experience in an environment of change and continuous improvement. 
• Must be an active, productive and collaborative member of the Legal and Compliance Department who works well across functions, lines of business and geographies Ability to work in a matrix organization.

• Strong managerial and team leadership skills.

Physical Requirements

• Ability to travel up to 25% of the time.

Have knowledge of shop floor of sterile injectables, Media fill validation, cleaning validation.

Implementation of all quality systems in accordance with current Good Manufacturing Practices.

·       To review and approve the standard Operating Procedures.

·       IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities.

·       Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release.

·       To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing.

·       Material master data management and Vendor/ Service Provider qualification.

·       Any job activity assigned by HOD.

·       Review of NDC request.

·       Handling of SAP activities.

·       To ensure distribution, Retrieval and destruction of document as per defined procedure.

·       To investigate the deviations, incidents, Out Of Specification, Out Of Trends

·       and non-conformances at the site and escalate the major observations to senior management.

·       To allot document number and equipment number as per procedure defined in procedure.

Candidate should have experience on injectable quality system and validation activity.

Candidate should have exposure on Documentation and QMS activity.

Ensure the online documentation in warehouse activity.

Perform the dispensing activities in the Formweigh.Net system.

Stage review of executed BMR/BPR and compliance.

Line clearance of dispensing activity.

EMS alarm acknowledge and report generation for batch.

Ensure the online documentation in warehouse activity.

Co-ordinate with Production & PPIC department for dispensing priority.

Keep area ready to face internal, External, and regulatory audits and inspections.

Responsible to perform and verification stock cycle counts as per schedule.

Receipt and dispatch of Finished goods.

Responsible to keep the workplace neat and clean. Maintain 5S and support for its improvement

Ensure the compliance and completeness of activities.

To carry out any other related duties as required from time to time assigned by the management.

Lead and Responsible for the document planning as per the PPIC and Product launch timelines. Utilization of resources as per the work demand and target timelines. Effective coordination with CFT and other site teams for smooth flow of documentation activities. Training to the Doc cell team, in design of document as per end user feasibility and quality compliance.   Review and Approval of the Documents. Ensuring the Product specific CPP and regulatory filing commitments. Co-ordination with US team for projects wherever applicable. Support to the Production for continuous improvement and feasibility changes in documentation for better compliance. Supporting to team for driving the Investigation /Deviation procedural investigation and report closure.