Qa Opening Assistant Manager Job in Fdc Limited

Roles and Responsibilities

• To ensure compliance with the principles of Data Integrity.
• To ensure compliance to Entry / Exit procedures.
• To maintain Personal Hygiene
  Responsibilities towards ensuring cGMP Compliance in the facility
• Taking GMP round in facility and ensuring cGMP Compliance w.r.t. facility upkeep, online documentation & effective implementation of quality system procedures.
• Bridging gaps identified during GMP round by extending technical support to the responsible departments.

Responsibilities towards Customer & Regulatory Audits.

• Core team member in Audit Preparation
• Review of Compliance status of previous audit observations
• Monitoring progress of Audit
• Sharing Audit report amongst the concerned departments.
• Arranging meeting for discussing audit report & following up with the concerned department for draft response.
• Drafting Audit compliance based on the response received from the concerned departments.
• Finalizing the Audit compliance report in discussion with Head QA and Unit Head.
• Timely Submission of Compliance report to CQA and resolving CQA concerns if any in the compliance report.

Responsibilities towards Internal audit conducted by CQA.

• Sharing Audit report received from CQA amongst the concerned departments.
• Arranging meeting for discussing audit report & following up with the concerned department for draft response.
• Drafting Audit compliance based on the response received from the concerned departments.
• Finalizing the Audit compliance report in discussion with Head QA and Unit Head.
• Timely Submission of Compliance report to CQA and resolving CQA concerns if any in the compliance report.
• Tracking and follow up with the concerned departments for completion of pending tasks.
• Ensure implementation of the planned actions as per committed target timelines.

Responsibilities towards Self-Inspection

• Monitoring progress of Self Inspection as per the schedule.
• Audit team member for each Self inspection.
• Conducting audit as per schedule along with the other Auditors.
• Co-ordinating with Lead Auditor for finalization of the Audit Report & sharing Final Audit report with QA-Self Inspection Co-ordinator.
• Reviewing draft compliance report.
• Discussing Final Compliance report with CQA and resolving CQA concerns if any in the compliance report.

Responsibilities towards tracking of QMS elements for effective implementation;

• Review of Excel Trackers of Change Controls (Site/ Corporate), Deviations, CAPA & monitoring.

QMRM KPI discussion with corporate. Discussing comments sent by corporate QA with concerned person and QA Head on QMRM report and replying to the queries. Arranging and sending updated excel sheets to CQA.

Spot Audit.

• Checking the activity performed, training records on activity, questioning the employee and evaluating the records.
• Checking training files of employee for timely updation and completeness.
• Ensuring compliance of gaps/ non conformances identified during spot audit.

Validation & Qualification

• Team Lead in Validation/ Qualification activities.
• Coordinate with other Sections Head of QA & extend/seek support required if any to meet daily targets.
• Review & Updation of Validation Master Plan & Site Master File.
• Monitoring progress of Validation & qualification activities inline with the VMP.
• Coordinating with Production, QC & Engineering department on Validation activities. Arranging meetings whenever required for scheduling validation/ qualification activities.
• Review of draft Process/ Cleaning Validation/ Revalidation Protocols, Hold Time Study Protocols, Equipment requalification protocols.
• Review of Cleaning validation matrices.
• Preparation of Performance qualification protocols.
• Identifying Sampling Location for Cleaning Validation Sampling.
• Ensuring availability of required approved documents prior to proceeding with validation/ Qualification activity.
• Scheduling & monitoring sampling activity for ongoing validations/ qualifications.
• To expedite delays if any in sampling or sample handover or usage decision in SAP for Validation samples through appropriate planning.
• Monitoring online execution of Validation/ Qualification protocols.
• Following-up with QC for Analytical Results of Validation Samples.
• Timely compilation of Validation/ Qualification Summaries or their review.
• Review of executed validation/ qualification protocols and summarizing validation results.
• Technical assessment of the data & conclusion of validation summaries.
• Active participation in investigation of deviations or non-conformances identified/ reported during validation/ Qualification study.
• Ensure online updation of traceability matrix of the equipments/ instruments with review and completion status.
• Review of Usage log of Sampling Equipments & ensuring its timely updating.
• Ensuring appropriate maintenance of sampling equipments.
• Ensuring appropriate storage of Validation/ Qualification Records.

Risk Assessment.

• Preparation of protocol, identifying risk, evaluation, assessment of current control measures, proposing additional control measures. Arranging meeting and discussion with concerned department on identifying control measures, deciding timeline for implementation and tracking its compliance.
• Summarizing Risk Assessment report.
• Tracking periodic review of risk assessment protocol.
• Maintaining Risk assessment logs and records therein.

Documentation:

• Review of draft SOPs, identifying gaps & providing technical support in closing the gaps.
• Review and updation of training module.

Training

• Imparting Training on SOPs/ QAPs/ Topics covered under Annual Training Plan & evaluation of the training questionnaire.
• Imparting training triggered towards CAPA & evaluation of the training questionnaire
• Training effectiveness monitoring wherever applicable.

Education-

UG:B.Sc in Any Specialization

PG:M.Pharma in Any Specialization

Doctorate: