Senior Executive - Quality Assurance Formulations - Ipqa Job in Syngene International Limited

Job Purpose:

This role involves in performing line clearance and in-process QA activities at shop floor.

Job Description:

Key Responsibilities:

• Line Clearance during Batch change over.
• Performing of sampling either required for in-process testing, finished goods at manufacturing area.
• Issuance and review of Manufacturing documents (MFR, BMR, BPR, SOPs, EOPs, IOPs and Technology transfer documents) logbooks and annexures for Execution Pertaining to Formulation units.
• Filling and Maintenance of Quality Documents and Records.
• Preparation and Review of Cleaning validation, process validation, hold time protocols and reports.
• Handling of internal audits, client audits and regulatory inspections.
• Responsible for the monitoring and review of QMS, Documentation and Records of Formulation Development Center (FDC) and S15-GPP.
• Initiation and assessment of Change Controls, Deviations, CAPA, OOS, OOT, Risk assessment, batch failure and customer complaints investigations.
• Provide line clearance for material management and warehouse.
• Perform activities related to SAP i.e. batch no. allocation, Batch record issuance.
• Conducting cGMP inspections across the manufacturing plant and supporting area.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification: M.Sc. / M. Pharma

Technical/functional Skills:

• Should be well versed with current regulatory requirements and sufficient knowledge in OSD facility.

Experience: 3-5 years

Behavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

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.