Piramal Pharma Hiring For QA Dept
Deputy Manager - Quality Assurance
Qualification: B.Pharm
Job Location : Mahad, Maharashtra, India
Job Description:
Perform site R& D routine activities, Validation Activities, and Internal audit/gap assessment as per FDA 6 system and DI (Data Integrity).
Lead remediation plan and restore
To understand the business & product needs to system establishment and sustainability.
In the process, it requires interactions with different departments and assessing the complexities of current processes.
Prepare risk papers, and position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business sustenance, and business continuity.
Identify quality requirements by reviewing regulations, guidelines, and standards, including USFDA, EU GMP, ICH, ISO, FSSC 22000, ISO 45001 & HACCP. Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
Lead, manage, and ensure proper training to any relevant change management programs for the R& D Department.
Represent Quality at senior management and review meetings.
Review / Distribution of Tech Transfer, CDS, and specifications from the R&D Dept & other customers.
Review & updation of STPs & specifications as per the current pharmacopeias.
Preparation and review of quality risk assessments.
To review & approve SOPs, specifications, and test methods of the products.
Review of calibration certificate (External/internal)
Review & verification of Method validation, cleaning validation & process validation.
All R& D related documents, records, audit trail, and raw data shall be reviewed.
Preparation and updation of R&D departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2
Review of Change control, deviation, incident, CAPA, OOS, OOT & market complaint.
Ensuring the quality and integrity of all GXP data and documentation generated.
Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111.
Ensure the 21 CFR Part 11 compliance in the Laboratory.
To fulfill the analytical requirements of FSSAI regulation.
Adherence to the requirements of EHS norms.
To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
To implement QEHS policy & objectives.
To ensure participation and consultation of workers.
Ensure the use of PPE
To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
To ensure the work permit system during maintenance activities.
To implement QEHS continual improvement projects at the site and monitor.
To ensure disposal of waste.
Authorised to prevent improper workplace conditions.
Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
Authorised to prepare OH&S performance document.
Authorised to conduct training of workers related to OHSMS.
Apply Link
Post a Comment