Manager

Reposted 10 Days Ago
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Panoli, Bharuch, Gujarat, IND
In-Office
Mid level
Biotech • Pharmaceutical • Chemical • Manufacturing
The Role
The Manager ensures compliance with QMS and audit procedures, establish quality systems, approve documentation, and lead a QA/QC team to enhance organizational performance. Responsibilities include vendor audits, investigation of complaints, process improvements, budgeting, EHS compliance, and knowledge management.
Summary Generated by Built In
  1. To ensure QMS and Audit compliances at Panoli crop manufacturing sites of Hikal Ltd.
  2. Establish, maintain quality system for effective functioning of Quality (QA & QC) Department  and maintain within KPI.               
  3. Establish Standard Operating Procedures (SOPs) / standard test procedures (STP)/ specifications for RM/PM/FG including in-process sampling plan, to maintain and improve organizational performance.  
  4. Approval of Batch Production Control Records (BPCR's), Annual Product Qualification Report (APQR), Continued Product Verification Summary (CPV), Product Assurance plan (PAP), Contamination Prevention Risk Assessment (CPRA), Process Validation, Instrument/ Equipment Qualification protocol & reports and other documents.    
  5. Review of new vendor analysis report & maintain record. Visit/Audit vendor facility for
  6. Reviewing  and approval of finish product, In-process, intermediate & raw material product sample results as per SOP.     
  7. Review & approval of reference standard development & it's validation. 
  8. Ensure the dispatches/ analysis of material as per marketing plan/business requirement.       
  9. Approval of Purchase Requisition related to QC and QA department.   
  10. To ensure appropriate investigation of customer complaints, audit compliance, OOS/, OOT,
  11. To ensure prevention of contamination and cross contamination activity.          
  12. Ensuring the availability of adequate competent resources at quality unit to achieve the
  13. Process Improvement, Review new process & provide suggestions to the production process & achieve higher                        levels of quality at lower costs.          
  14. Implement improvements as per the internal customer requirements, when required. Track

             qualification.   

             Approval of analytical method development/validation/verification/transfer protocol and reports.            

          deviations and tracking for implementation of their RCA and CAPA. 

              departmental goal and contamination prevention objectives.      

              progress on process improvement programs that have been initiated.            

             15.        Budgeting

  • Participating in projects team for feasibility evaluation and for new product implementation budgeting.
  • Keep own operations within allocated budget; contribute to reducing quality operation cost

             16.        EHS

  • To ensure the proper filling of work permit system, safe handling of lab chemicals, samples, standards, use and availability of PPE's to avoid personal injury.
  • Follow safety procedures. Establish, Ensure & Supervise safe and good laboratory practices.

             17.        Knowledge Management & Capability Building

  • Ensure documentation according to statutory norms & other standards.
  • Responsible for developing quality consciousness & capability among all QC technical staff. Keep upto date with best practices in the industry & analyze the possibility of adoption & utilization of these at Hikal.
  • Lead the team of 10-15 People in QA/QC staff to get high performance along with speed and accuracy for the QA/QC  activities .

18. Team and People Management

                                                         



Authorities



  1. Approval/Rejection of material (Raw, Packing & Finish Goods).
  2. Access the QC laboratory, control samples and records.
  3. Recruitment of the QA/QC personnel for Panoli in coordination with Corporate Quality Head.
  4. Final approval for acceptance of any RM/ PM under deviation in coordination with business
  5. To grant leave to reportee and issue the gate pass to QA & QC staff.

and site Head.

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The Company
HQ: Navi Mumbai, Maharashtra
2,520 Employees
Year Founded: 1988

What We Do

Established in 1988, Hikal is a reliable partner to companies in the Pharmaceutical, Animal Health, Biotech, Crop Protection and Specialty Chemical industries. We manufacture and supply quality Active Ingredients, Intermediates, Biocides to the global life sciences industry. Hikal has five manufacturing facilities in India at Maharashtra (Taloja and Mahad), Gujarat (Panoli) and Bengaluru (Jigani) and a world-class Research & Technology centre at Pune. Our facilities have been inspected and certified by the respective Global Regulatory Authorities. We create and deliver sustainable solutions for our partners and customers across the life-sciences value chain. Hikal is the partner of choice for: • Pharmaceuticals (Human & Animal Health) APIs, Generics, Custom Manufacturing, Intermediates and Advanced Intermediates • Crop Protection & Specialty Chemicals Active Ingredients, Advanced Intermediates, Intermediates • Research & Technology Process Development, New Product Development, Contract & Custom Development Hikal is the first Indian life-sciences company to receive the Responsible Care® certification governed by the International Council of Chemical Associations (ICCA).

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