Careers

Company : Seqens India (Monolom India)

Location : Pune

Position : Scientist

Department : AR&D (Analytical Method Development)

Qualification : M.Sc. Analytical Chemistry / M Pharm

Experience : 8 - 11 years

Job Responsibilities:

• Develop analytical methods for identified projects using different analytical techniques.
• Establish good development practices aligned with IL practices.
• Perform Literature search for the projects under development.
• Plan and support SRD for routine activities.
• Update ongoing project progress via presentation and present during project meetings.
• Perform Carry over studies for genotoxic/ non-genotoxic impurities of Raw materials, Intermediates and Final API
• Carry out analytical method feasibility including preparation of reports as and when required.
• Preparation and updating standard operating procedures.
• Monitor daily calibration of lab instruments as per schedule.
• Carry out hold-up study, stability, tech transfer of analytical methods with preparation of protocols and reports.
• Prepare and review Method of Analysis, specifications, and standard operating procedures as per SOP
• Provide analytical support during process transfer to Israel plant.
• Identify the category of standards in a project and plan for the completion of Qualification of all reference standards meeting timelines

Company : Seqens India (Monolom India)

Location : Pune

Position : Associate Scientist

Department : AMV (Analytical Method Validation)

Qualification : M.Sc. Analytical Chemistry / M Pharm

Experience : 4 - 6 years

Job Responsibilities:

• Hands on experience on HPLC, Potentiometer & Potentiometer & other chemical test.
• Carry out analytical Method validation including preparation of protocol and reports.
• Review analytical method validation (Raw data, LNB & excel ) including protocol & report.
• Handling of lab incidents & troubleshooting.
• Perform GMP & GLP documentation.
• Perform Calibration & Qualification of instrument.
• Maintenance of working standards reference standards primary reference standards primary chemical substance , impurity standards & GC working standards with reconciliation.

Company : Seqens India (Monolom India)

Location : Pune

Department:  Analytical Method Development

Designation: Associate Scientist

Qualification: M.Sc. Analytical Chemistry / M Pharm

Experience: 4 – 6 years

Job Responsibilities:

• Develop analytical methods for identified projects using different analytical techniques.

Establish good development practices aligned with IL practices

• Perform literature search for the projects under development
• Plan & support SRD for routine activities
• Update ongoing project progress
• Perform carry over studies for genotoxic /non-genotoxic impurities of Raw materials intermediates & final API
• Carry out analytical method feasibility including preparation of reports as when required
• Perform the testing of raw materials , In process , finished product & stability samples
• Documentation of analytical data & test result in lab notebooks
• Preparation and updating standard operating procedures
• Perform calibration of lab instrument as per schedule
• Prepare test requests of the sample sent to external testing laboratory with required documents and follow up
• Maintain compliance in the laboratory work as required by current regulatory requirements
• Carry out hold up study , stability , tech transfer of analytical methods with preparation of protocols & reports.

Site Quality Head

Vanamali site

Responsible for establishing and operating a quality assurance system in the company, according to required regulations and policy. Accountable for ensuring all-time readiness of plan for various GMP compliance audits, being the single point contact on all Quality matter

Job Description:

• Develop, implement, manage, audit, and maintain GMP quality systems.
• Coordinate and perform all vendor qualification and compliance audits.
• Develop, manage, and maintain a GMP compliant document control system.
• Oversee investigations of all non-conformances (deviations, market complaints etc.
• Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company.
• Work across all disciplines (e.g., manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
• Provide quality guidance to product development projects and programs.
  
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
• Ensuring the development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially.
• Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
  Ensuring that there is a self-inspection programme in place which is communicated to Operations to meet the requirements of USFDA, EU GMP/PICS/TG/MHRA etc.
• responsible for preventive and corrective actions throughout the company
• Responsible for handling customer complaints from receipt of the complaint, take corrective action and respond to the customer in the end
• Updating the company's management on all critical issues relating to product quality or compliance

Job Requirements

• Qualification: B. Pharm./M. Pharm./ M. Sc. With any additional Quality related qualification
  Experience as Quality Manager- at least 5 to 10 years
• Knowledge & Experience from Pharma/API industry

Key Competencies:

• Passion for Excellence
• Leadership & Team Management
• Result Orientation &Multi-Tasking
• Good Communication Skills