Senior Manager – Quality Assurance | Sun Pharma | Paonta Sahib

Job Description

• To ensure compliance from a training standpoint during audits.
• To impart/coordinate for completion of various types of training like on-the-job training, refresher training, and ILT training.
• To ensure training completion of QA/ QC.
• Ensure SOP training of staff is performed prior to execution of critical tasks.
• To ensure the effectiveness of training provided to employees and assessment of the effectiveness of the overall training program through periodic, for-cause, or routine audits.
• To establish training documentation standards to ensure appropriate retention, archival, and retrieval processes for executed training records and training materials.
• To review and approve the Department Training Plan Matrix which defines the training curriculum required for each job role. To review, manage, document, and approve any changes to curricula through Department Management.
• To provide support for GQS/GSOP implementation at the site by assessment and evaluation of these Global documents as per established standard procedure(s).
• To maintain all-time SOP readiness by updating the SOP master list.
• Ensure that internal audits are executed as per the pre-approved schedule and strategy in accordance with established SOPs and cGMP regulations.
• Ensure that documents required for internal audits are timely approved and shared with concerned auditee(s)/departments
• To coordinate for finalizing of audit team based on objective and scope of the audit, to coordinate with corporate quality assurance during site audits as required
• To perform QA review and classification of observations during internal audits
• Ensure that audit observations are adequately documented in the audit report and shared with concerned stakeholders within stipulated timelines as mentioned in SOPs
• Ensure that audit responses are received and reviewed for completion and justification as required; also CAPA (s) are provided with timelines
• Ensure that CAPA (s) are implemented as per compliance procedure, effectiveness is monitored and documented as per SOP requirements
• Ensure that trending of audit observations are compiled, reviewed, and approved as per timelines mentioned in SOP
• Ensure through continuous monitoring on the shop floor that all-time readiness (ATR) is maintained at the Site
• Ensure that implemented CAPA (s) and previous audit observations are in compliance to the response provided
• Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.
• Provide appropriate training and development to support staff to meet their respective job responsibilities.
• To conduct an impact assessment and risk classification for audit observations, deviations/change controls/investigations, and other CQMS records.
• Ensure that engineering calibration certificates, layouts, and other documents related to utilities and facilities are approved in a timely manner.
• To provide QA support for approval and closure of investigations, deviations, out-of-specifications, CAPA, and out-of-trend results.
• Ensure coordination with the cross-functional team for timely and effective implementation of quality system-related projects and training.
• The assessment of the laboratory deviations, lab events, and investigations for non-conformances in the laboratory with Good Laboratory Practices, Standard Test Procedures, and Specifications.
• The assessment of the laboratory investigations/shop floor investigations of Out of specification and verification of the data.
• Final review of analytical data and manufacturing documents of exhibit batches for clearance to a regulatory filing.
• To ensure compliance to cGMP, review and track non-conformances and QC data as required by laboratory QA procedures. Immediately communicate significant concerns identified to QC Head, QA Head, and Site Quality Head to ensure that questionable test results are not released. Ensuring the implementation of CAPA.
• Assist with and /or advise on laboratory procedure development and implementation as requested or necessary to support continuous improvement. Perform periodic reviews of SOPs as per schedule.
• To participate in Management Review Meetings and other Quality Team Meetings.
• Review and approve exhibit stability protocols generated by PDR/PDL/Stability department.
• To ensure implementations and compliance of CAPA on observation of regulatory audits and internal audits conducted by QA and CQA with respect to laboratory compliance.
• To review and approve qualification and validation protocols /reports/-laboratory equipment qualification, analytical method validations/verifications.
• To investigate the cause of observation of audits (internal, external, and regulatory) on laboratory control systems and to implement CAPA.
• To do a risk assessment of the current state of compliance with proposed effective pharmacopeias changes/variations under approvals.
• To ensure Quality and compliance of standalone computerized systems.
• To ensure quality and compliance of computerized systems for any upcoming activity.
• Participation in self-inspection activities as subject matter expert.
• Review and approve change controls.

Qualification: B.Sc, B.Pharma, M.Pharma, MS/M.Sc