Website:
manipalsplchem.com
Job details:
Overview:
The Manager – QA will have overall responsibility for establishing, implementing and maintaining the Quality Assurance systems for laboratory, R&D, pilot and production-related activities.
The incumbent will be responsible for ensuring that raw materials, intermediates, finished products, analytical methods, manufacturing processes, documentation, suppliers, customers and laboratory activities comply with applicable quality standards, specifications, regulatory requirements and customer expectations.
The position requires strong hands-on expertise in QA, validation, quality systems, audits, vendor qualification, customer compliance, SOP/BMR preparation, deviation/CAPA, change control, specifications and pharmacopoeia requirements.
The person should be capable of independently establishing a robust quality system suitable for a growing specialty chemical/API organization.
Key Responsibilities:
QA Responsibility
- Take overall ownership of QA activities across R&D, laboratory, pilot and production-related operations.
- Establish and maintain an effective Quality Management System (QMS).
- Ensure quality systems are implemented and followed on a day-to-day basis.
- Define quality standards, specifications, testing requirements and acceptance criteria for: Raw materials, starting materials, Intermediates, In-process materials, finished products, Packaging materials, Process-related samples
- Ensure complete traceability of analytical and quality records.
- Monitor laboratory compliance and ensure good documentation practices.
- Establish appropriate systems for sample management, testing, review, approval and release.
- Ensure that quality decisions are based on scientific data, documented procedures and applicable regulatory requirements.
Quality Assurance Systems
- Establish, implement and continuously improve QA systems covering: SOP management, Specifications, Master documents, Batch documentation, Deviations, CAPA, Change Control, OOS/OOT investigations, Risk assessment Internal audits, Supplier qualification, Customer complaints, Product quality reviews, Training, Document control, Data integrity, Qualification and validation, Record retention.
- Ensure that all applicable procedures are not only documented but effectively followed in day-to-day operations.
SOP Development & Compliance
- Draft, review, approve and implement SOPs related to QA, QC, laboratory and production quality systems.
- Establish SOPs for Sampling, Testing, Instrument operation, Calibration, Cleaning, Analytical method execution, Method validation, OOS/OOT, Deviation, CAPA, Change Control, Vendor qualification, Audit management, Batch documentation, Data integrity, Reference standards, Stability studies, Retention samples, Document control
- Conduct periodic SOP review and ensure timely revision.
- Ensure personnel are trained before implementation of new/revised SOPs.
Production Quality & Manufacturing Support
The candidate should have sufficient understanding of manufacturing operations to ensure quality throughout the production process.
Responsibilities include:
- Provide QA/QC support to R&D, pilot and production activities.
- Review and establish appropriate in-process controls (IPCs).
- Support development and approval of manufacturing processes.
- Review manufacturing process parameters from a quality perspective.
- Draft/review Batch Manufacturing Records (BMRs) and related manufacturing documentation.
- Establish appropriate sampling plans and testing requirements.
- Review batch records and analytical results before batch release.
- Ensure deviations occurring during manufacturing are properly documented and investigated.
- Support process validation and cleaning validation activities where applicable.
- Ensure product quality is maintained during scale-up from laboratory → pilot → commercial manufacturing.
- Work closely with Production, R&D, Process Development, Engineering and EHS teams to resolve quality-related issues.
BMR / BPR & Manufacturing Documentation
The candidate should be capable of independently preparing or reviewing:
- BMR – Batch Manufacturing Record
- BPR – Batch Packaging/Processing Record, where applicable
- Master Batch Records
- Manufacturing instructions
- Sampling plans
- In-process testing requirements
- Finished product specifications
- Raw material specifications
- Packaging material specifications
- Yield reconciliation requirements
- Batch release documentation
Ensure that manufacturing documentation provides adequate traceability, accountability and control of critical process parameters and quality attributes.
Vendor Qualification & Supplier Quality
Strong experience in vendor qualification and supplier quality management is mandatory.
- Evaluate and qualify suppliers of Raw materials, Starting materials, Intermediates, Chemicals, Packaging materials, Critical services, External analytical laboratories
- Review supplier documents including Specifications, CoA, MSDS/SDS, Quality agreements, Manufacturing process information, where required, Regulatory/compliance documents
- Conduct or coordinate supplier audits.
- Prepare vendor audit questionnaires and checklists.
- Review supplier audit findings and CAPA.
- Establish vendor approval and periodic requalification systems.
- Monitor supplier performance and quality trends.
Customer Quality & Compliance
The candidate will be responsible for ensuring compliance with customer-specific quality requirements.
Responsibilities include:
- Understand and implement customer specifications and quality requirements.
- Review customer quality questionnaires.
- Respond to customer technical and quality queries.
- Support customer audits and quality audits.
- Prepare responses to customer observations.
- Coordinate CAPA commitments with relevant departments.
- Review and approve customer-specific specifications and testing requirements.
- Ensure commitments made to customers are implemented and sustained.
Audits & Inspection Management
Responsibilities include prepare audit plans and checklists, Coordinate audit schedules, Lead audit preparation activities, Host auditors and coordinate responses, Identify gaps and compliance risks, prepare audit responses, Establish CAPA for audit observations, Track CAPA effectiveness and closure, Ensure continuous audit readiness.
Deviation, CAPA, Change Control & Investigation
Responsibilities include Conduct scientifically sound root-cause investigations, Apply appropriate root-cause analysis tools, establish corrective and preventive actions, evaluate impact on product quality, ensure timely CAPA implementation and effectiveness checks, Review and approve change controls, Assess quality/regulatory impact of proposed changes.
Data Integrity & Documentation
Ensure high standards of documentation and data integrity across QA activities.
Ensure proper control of: Raw data, Chromatograms, Instrument records, Laboratory notebooks, Analytical worksheets, electronic records, Audit trails, CoA, Batch records, Quality records.
Stability & Retention Sample Management
- Establish and manage stability study programs where applicable.
- Define stability protocols and testing requirements.
- Review stability data and trends.
- Establish appropriate storage conditions.
- Manage retention samples.
- Investigate stability failures or abnormal trends.
- Prepare stability reports and summaries.
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