Quality Control Lead

Job Purpose

• Accountable for the following activities;

GLP compliance, internal audits, Lab Investigations, Lab Safety, EHS, and Risk management related to Quality department and Values & expectation of the Organization.

Support to the production department to meet the manufacturing schedules by timely release of Raw materials / finished products / stability / validation / packaging material / testing etc.

Key Responsibilities

To ensure testing and release of raw material ,excipient, packing material, microbiological sample, bulk and finished product.

To ensure stability program conducted as per protocol

To support validation team for process validation samples analysis management

To ensure qualification ,calibration and maintenance of all laboratories instruments

To ensure OOS investigation and reporting in time

Control on lab. Related SOPs / PQS / PMSP Reviews as per schedule

Control on Reference standards management require for QC Laboratories

To ensure CAP / ATS compliance

To ensure that the activities in the QC Lab are in compliance with regulatory requirements

To ensure Compliance and inspection readiness

Verify compliance to Good Laboratory practice and Schedule L1of D & C act

To conduct initial assessment of change control raised in area of operation

Ensure monthly L1 audit of EHS / Quality as per schedule to identify gaps & timely closure of actions.

Reduction in the cGMP noncompliance coming from L1 / L2 / L3 / L4 audit and WHO audits

Tracking of staff leave and promote for plan absenteeism. Unplanned absenteeism cases to be handle as per standard procedures.

One on one discussion with staff to maintain discipline and building their capabilities.

Coaching / counseling of staff for adherence to standards related to safety, quality & delivery.

Quarterly Performance discussion with staff and ensure recording of NMS performance in PDP card.

Coordination & monitoring of dept consumables & inventory.

Handling of electronic systems (e.g. Empower, MERP, VQD, VQMS, SLIMS etc.)

Resource management of laboratory to have smooth work function department is done in time.

Ensure procurement for item required for quality department is done in time

Site SQCS contact; ensure adequate QC support in vendor approval process .Timely analysis of purchase samples.

To complete the QMS training in time and ensure the compliance with QMS in your area of operation. To carry out the gap analysis as per the requirement.

To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements

Risk management for department, Control on risk Log, Preparation of STPs and tracking of risks.

To ensure monthly EHS meeting are happening and issues are discussed and sorted.

Encourage staff for proactively identification of unsafe condition & unsafe behavior. Report it through ZAP process.

Responsible for control on Chemical reagents and special hazards including sensitizers, Sensitizing and Biological agents

Build an culture of reporting safety incidents and its closure within timeline with appropriate CAPA.

To provide and support of EHS activities in Quality control.

To ensure prevention of first aid cases / accident in department.

To promote safety culture in Quality control department.

To participate in RCAs as per requirement

Ensure compliance to GPS principles (LSW, Gemba,3Z etc)

Drive improvement with an approach of Kaizen & CIF.

To ensure continuous improvement in laboratory working and to impart working of QC staff

Support the functional head to establish the activities assigned or identified as and when basis.

To provide authorization / approval of QC documents.

Control on safekeeping of controlled substances in QC laboratory.

Scope of Accountability

Attendance Management.

People Development.

Manpower Planning.

Area Management.

Site critical CIF delivery.

Level 2 audit completion.

Delivery of department budget.

Quarterly OT not exceeding 105 hrs and maintaining OT budget for month.

Ensuring no overdue QMS action in dept.

Educational Background : M.Sc / B.Pharm / M.Pharm

Job-Related Experience :

14-18 years experience in Pharmaceutical Plant, 10+ years in QC

Acquaintance with respect to job requirements

Advanced knowledge of computer software & potency in use of computer software

Leadership skills

Resource Planning

Problem Solving

Effective communication skills

Ability to build relationships (Team building ) at all levels and across functions.