Executive / Sr. Officer - Quality Assurance

Position: Executive - QA (DMS)

• Required Experience : 4 to 6 years
• Qualification: M.Pharma/ B.Pharma
• Preference: Early Joiner.

Role & responsibilities

• To manage the issuance and control of standard operating procedures and protocols.
• Responsible for procurement, issuance, tracking, and retrieval and archival of reviewed bound books.
• To issue and track the issued training records and its related documents.
• Responsible for preparation and review of Annual Product Quality Review.
• To issue and archive the BMR and BPR. To manage Soft copy of all the master documents. Issuance.
• Responsible for issuance of deviation, change control, CAPA, and tracking its closure Introduce in the preparation and review of change control & deviation investigation.
• Preparation and review of SOPs.
• To handle approved drawings, its archival in documentation cell and its controlled To allot the technology transfer number and distribute the controlled copy of technology transfer documents to respective user departments as required.
• To be responsible for SAP related transaction.
• To handle control sample related all activity.
• To Review and Approve the shade card.
• To verify and maintain technical agreement with the service providers/contract agencies.
• To perform all the tasks assigned by the senior or reporting authority.
• Assessment of Change control in absence of reporting manager.

Position: Sr. Officer - QA (Equipment Validation)

• Required Experience : 3 to 4 years
• Qualification: M.Pharma/ B.Pharma
• Preference: Early Joiner.

Role & responsibilities

• To prepare and review Validation Master Plan (VMP), Qualification Master Plan (QMP), Process Validation Master Plan (PVMP), Cleaning Validation Master Plan and Computer System Validation Master Plan (CSVMP).
• To follow the validation master plan.
• To prepare and review Qualification and Validation Documents and execution as per protocol.
• To update equipment and utility periodic requalification / re-verification schedules on monthly basis or whenever required.
• Handling and storage of all quality. document like BMR, BPR, log book, Protocol and SOP.. throughout life cycle.
• To prepare and review standard operating procedures (SOP's) and procedures relating to qualification and validation.
• Preparation and review of URS, FS, DS, DQ, RA, IQ, OQ & PQ and summary reports for Equipment, System and Utilities.
• Coordination with cross functional team to perform qualification / requalification and validation activity.
• Addressing any deviation identified during qualification / requalification and validation activity.
• Performing qualification and requalification activities using data loggers I validator, Issuance, retrieval of logbooks and ensure integrity of book of rec~rds. Training departmen activities handling.
• To participate in investigation.
• To support in change management, deviations, CAPA and all other quality managementsystems as and when required.
• To participate Process Validation and Cleaning Validation studies.
• Review of required calibration reports, preventive maintenance, and work request and breakdown reports.
• Work in teams. Work along with cross functional team, Work by adhering to discipline of the site and organization, Protect the property of the organization.
• Any other work assigned by reporting authority/ Lead/ Head time to time.
• To Support the IPOA and OMS for In-Process activity and for building OMS system