Piramal Pharma Ltd
Website:
piramalpharma.com
Job details:
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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Deputy Chief Manager - Quality Control
Job Description
Job Description : Deputy chief Manager QC
- Ensuring analytical and technical support to production and QA for meeting all GMP and regulatory requirements. Ensuring the quality and integrity of all GxP data and related documentation.
- Ensuring that quality control documents, records, audit trails and raw data are reviewed.
- Release / Rejection of Raw materials and Packing materials.
- Ensure availability of adequate resources (quantity / quality) for QC to maintain compliance with GMP requirements.
- To approve or reject starting materials, packaging materials and intermediate, bulk and finished products in relation to their specifications, and evaluation of related records.
- To ensure that all necessary testing is carried out.
- To approve sampling instructions, specifications, test methods and other QC procedures, to approve and monitor analysis carried out at contract testing laboratory.
- To check the maintenance of department premises, equipment and instruments.
- To ensure that the appropriate validations, including those of analytical procedures and calibrations of control equipment/instruments are carried out.
- To ensure that the required trainings of quality control personnel are carried out and adapted according to need.
- establishment, implementation and maintenance of the quality system.
- supervision of the regular internal audits or self-inspections, participation in external audit (vendor audit) and participation in validation programs.
- Participating in the investigation of complaints related to the quality of the product.
- Participating in quality risk management program.
- Establishing, validating and implementing Quality Control procedures.
- Ensuring good house-keeping and accident free working in the Laboratory
- Provide inputs to manufacturing and R&D work process to ensure quality by design.
- Responsible for any additional projects agreed by quality management.
- Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed in a comprehensive manner.
- Define quality control goals and strategy in line with Piramal compliance, Product quality control management objective and regulatory requirements.
- Responsible for designing, implementing and ensuring compliance to all quality control related SOPs at site.
- Harmonization of Quality Control procedures.
- Continuous evaluation / maintenance of QC facilities/equipment, instruments and their Annual maintenance (AMC) as per current standard.
- Ensure fully engagement and involvement of subordinates regarding awareness and clarity related to data integrity requirements.
- Knowledge of EHS – Demonstrates basic knowledge of environment, Health and safety requirements within work area in order to comply with the standards, identification and escalation of potential hazards.
- Investigation Skills – Demonstrates expert knowledge of investigation procedures and tools, domain knowledge, impact assessment and implications on related areas in order to have comprehensive investigation to avoid repetition of issues/incidents, review trends and understand issues impacting organization and design CAPA.
- Collaborations & Trust - Identifies builds and maintains strong and sustainable partnerships based on trust, with different stakeholders across teams and within the team, functions and geographies to meet business objectives.
- Customer Centricity - Reinforces the importance of being customer focused; encourages a culture that values customers while monitoring and acting on their feedback from customers. Always focuses on delivering solutions that meet customers’ need.
- Takes action to promote and implement innovative ideas. Takes initiatives and encourages innovative solutions at work by trying different and novel ways while handling work problems or opportunities.
- Report all deviations which may have impact on safety, identity, strength, purity & quality of drug product.
- Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 111.
- Ensure the 21 CFR Part 11 compliance in the Laboratory.
- To co-ordinate with external agencies for technical support.
- Ensure the updating of Master specification for RM/PM/FG/SFG in SAP system.
- As a roll of Reviewer, Quality Control SOP reviewed in ENSUR system.
- Ensure that the testing of Raw materials, packing materials, in-process samples & Finished Goods is carried out as per STP.
- Ensure Analysis & reporting of stability products as per schedule.
- To ensure procurement, Planning and timely qualification of laboratory Standards required for routine analysis in QC lab.
- Ensure that the QC staff is following and maintaining the practices of cGMP & GLP.
- Ensure all quality reports, Data / Results entry as per SAP system.
- Ensure timely raising of deviations, quality events, change controls, OOS/OOT.
- Ensure all OOS / OOT/ Deviations are timely reported, investigated and closed.
- Ensure that the analysis & reporting of process validation samples are done in stipulated time.
- To ensure effective implementation of the Quality management system in Quality control department with respect to laid down procedures and systems.
- To carry out self inspections and ensure compliance to the audit observation.
- To ensure the compliance to the current ISO 9001, ISO 14001, ISO 22000, HACCP and SQF, WHO-GMP, UNICEF and other customer, Regulatory requirements and corporate Guidelines.
- Setting of Quality parameters for the Quality Control Department with interaction with R&D, which includes Specification updating, Technology transfer, Method transfer etc.
- To organize up-gradation of systems like documentation / SOPs / Analytical Services / Training / Budgetary exercises, w.r.t. Quality Control
- Imparting & organizing the Internal / External training activities for Quality control personals.
- To prepare & submit Monthly MIS Reports to Accounts & Quality Assurance dept.
- To monitor the destruction of respective records & retention samples of raw materials as per due expired schedule.
- The preparation of the budget activity likes CAPEX & OPEX for the current year with respect to Quality control dept.
- Preparation of training calendar and ensure the training imparted to all concern.
- 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 worker.
- To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same.
- To ensure work permit system during maintenance activities.
- To implement QEHS continual improvement projects at site and monitor.
- To take the overall responsibility of Quality control department
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