IPQA Team Member

2 months ago

Bengaluru, Karnataka, India Syngene Full time

Job Title: IPQA Executive

Job Location: Syngene International Limited

At Syngene, safety is at the heart of everything we do personally and professionally.

Mandatory Expectations

  • Overall adherence to safe practices and procedures of oneself and the teams aligned.
  • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards.
  • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
  • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
  • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.
  • Compliance to Syngene's quality standards at all times.
  • Hold self and their teams accountable for the achievement of safety goals.
  • Govern and Review safety metrics from time to time.

Core Purpose of the Role:

This is an exciting opportunity to play a role in GMP IPQA team of Syngene.

The role will provide independent assurance to the quality of the various stages of the process.

This role gives confidence on the integrity of process by ensuring the cleaning of equipment's prior and post the processes and giving line clearance to the different process steps.

It provides an assurance on the process quality and hence the final product getting manufactured avoiding any possible quality concerns after the process is completed.

Role Accountabilities

  • Preparation/revises/review of procedures (like SOP, protocols, reports, calibration schedule, and other related documents as applicable).
  • Review and approval of Executed BMR and PDR within SLA and ensure the compliance from the respective department.
  • Issuance and reconciliation of logbook and formats upon request from the cross-functional team. Responsible for issuance and control of BMRs, PDRs, SOPs, EOPs, and ECCs.
  • Verify the product details, batch no., quantity, label, purchase order, RM issue slip, CoA, weights, packing and dispatch record, and packing area (not limited to), and provide clearance to dispatch activity.
  • Verify the cleaning and ensure the area, equipment, and filter (not limited) is free from the previous product. Ensure proper labelling of equipment, calibration status, light fixtures, and missing equipment accessories and not limited to (Line clearance).
  • Identify the scope of improving productivity and reducing errors.
  • Co-ordination & participation during customer/third party CGMP audits, regulatory audits, and internal quality audits.
  • Ensure compliance with the observations of internal, Self-inspection, client, and regulatory audits.
  • Coordination & participation during Self Inspection.
  • Identify the gaps between SOP vs Practice/Guidelines and take appropriate actions.
  • Involving in the investigations to identify the root cause & to propose the appropriate CAPA.
  • Review specification within SLA and ensure compliance from the respective department.
  • Review of validation protocol and report & other analytical reports within SLA and ensure the compliance from the respective department.
  • Verification of routine and periodic audit trail and ensure the compliance from the respective department.
  • Archival of document and third party archival activity within SLA and ensure the compliance from the respective department.
  • Ensure training completion before startup of assigned activities. Provide the trainings to shop floor team on need basis.
  • Compliance monitoring by routine inspections in manufacturing facility, Quality control and warehouse.
  • Batch release activities in LIMS, SAP and other relevant activities.
  • Assessment and review of Cross department CAPA.
  • Material addition and MIC creation, material movement in SAP as per requirement.
  • Perform the Plant rounds to ensure the cGMP compliance.
  • Data logger report reviews.
  • GRN review and approval.
  • Plant support during day to day activities as per defined SOP's.
  • Environmental monitoring and plate release activities monitoring as per defined procedure/schedule.

Syngene Values

All employees will consistently demonstrate alignment with our core values

  • Excellence
  • Integrity
  • Professionalism

Specific requirements for this role

  • Experience
  • Demonstrated Capability
  • Education

Experience

Handled IPQA roles in Pharmaceutical GMP company

Knowledge on line-clearances for various stages of pharma process

Expertise on handling SAP, EDMS, LIMS and track-wise applications

Familiar with cGMP guidelines

Skills and Capabilities

Expertise in Line clearance requirements

Thorough knowledge in Pharma process and quality assurance requirements,

Knowledge on pharma process validation and cleaning validations

Capable of thinking scientifically to address complex problems and develop solutions

Work as a team and have collaborative mindset

Good communication skills

Education

M.Sc. in chemistry

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law.

In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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