HLL Lifecare Limited (HLL) is a Govt. of India Healthcare products manufacturing and services Company based in Thiruvananthapuram, Kerala, India under the Union Ministry of Health and Family Welfare, HLL is a global leader in the area of contraceptives, hospital products and healthcare services. With 7 manufacturing units, 5 subsidiary companies and having presence in more than 100 countries, HLL is positioned as a total healthcare solution provider catering to the well-being ofthe society at large.
Post : DEPUTY MANAGER (QA / QC and PRODUCT CERTIFICATION) (on REGULAR BASIS)
Department : HLL- AKKULAM FACTORY
Overall Job Summary : The Deputy Manager (QA/QC and Product Certification) shall monitor and coordinate the QA & QC activities for Sterile Medical Device manufacturing, meeting the regulatory requirements both Domestic and international as applicable Prepare and review product safety and performance documentation aby reviewing the manufacturing & design documents, product QC test reports, product & process validation reports, the international literatures, customer feedback, risk management files etc.
Duties and Responsibilities
1. QA/ QC activities during the commercial production of the Sterile Medical Devices
2. Preparation of Quality Manual, technical files, Clinical Evaluation records, Product dossier, Site master file, Validation documents and Stability records in line with the national &international regulations.
3. Analytical method validation as per the current regulatory requirements.
4. Coordination and performing the Customer Feedback collection, customer complaint redressel, post Market clinical follow up, Clinical Investigation, Clinical Evaluation and Risk Management.
5. Qualification of Lab & Production Equipments
6. Preparation, review, evaluation and approval of change control procedures, CAPA, deviations/ investigations, OOS/OOT investigations and inprocesses QA reports.
7. Coordinating with both internal and external interested parties
8. Coordinating with Regulatory affairs Department for manufacturing License and associated product approvals
9. Supervising and training the Quality operators for GMP, GLP and Documentation practices
10. Coordinating with Micro biology lab analysis and sterility testing
11. Coordinate with cross functions for audit schedule, Audit findings and corrective actions and preparation of audit compliance report.
Skills & Competency required for the job
1. Good knowledge of production and quality concepts extending to Sterile Medical Device production and testing.
2. Awareness in international legislations, guidelines and regulatory requirements pertaining to Sterile medical device manufacturing and testing.
3. Expertise in handling regulatory requirements and performing stability studies inline to regulatory requirements (i.e. MDR, ICH, and UNFPA).
4. Competent in review and documentation of analytical Method validation as per the current ICH and regulatory guidelines
5. In depth understanding on GMP,GLP and Good Documentation Practices
6. Competent in preparation of Quality Manual, technical file, clinical Evaluation records, Product dossier, Site master file, Validation documents and Stability records in line with the national & international regulations.
7. Competent in handling regulatory & customer audits and auditing knowledge as per ISO/GMP/IMDR/EUMDR/WHO and other required quality standards.
8. Good knowledge in Microbiological analysis/ sterility testing
9. Exposure to ISO 17025, ISO 9001, ISO 13485, IMDR, EUMDR, WHO and associated product standards/ regulatory requirements.
10. Updated knowledge of latest QA/QC techniques and data interpretation.
Maximum Age : 45 Years as on 01/12/2021
Scale of Pay (For Regular Appointment) : 16400 - 40500/-
Annual CTC : - Rs.8.3 lakhs (approx.) at the minimum of the scale.
Essential : M.Pharm
Desirable : PhD
Post Qualification Experience
Essential : Minimum Five years relevant Experience in Quality Assurance of sterile medical devices
Posting Location : Trivandrum
Candidates are advised to send the necessary documents to [email protected] on or before 05.01.2022.
Essential documents to be forwarded are:
1. Duly filled Application Form (Photo must be affixed)
2. Educational Qualifications (10th/ 12th/ Graduation/ PG (as per the advertisement)/ Other Additional Qualifications)
3. Post Qualification relevant Experience (As per the advertisement). Without necessary documents like Experience Letter/ relieving Letter/ joining documents, the experience required will not be counted. No further communication will be sent to the candidates in this regard. Candidates are advised to attach all relevant experience related documents carefully.
4. Updated CV with Mobile Number and email address
5. Community Certificate (for SC/ST/ OBC)or Disability Certificate (for PH)
6. Latest Pay slip
7. Aadhar card
Please mention the subject as “Application for DEPUTY MANAGER (QA/QC and PRODUCT CERTIFICATION) position”
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